Devices › Stents, drains and dilators for the biliary ducts
Device brand name · Catheter biliary diagnostic
Cre Pro: medical device reports filed with FDA
985 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code FGE.
- 985
- device reports naming the brand
- 0% of all MAUDE reports · about 117 a year
- 341
- reports, 12 months to August 2026
- 120 in the 12 months before
- 97.9%
- classified as malfunction
- 69% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 985 reports that name the brand "Cre Pro" (catheter biliary diagnostic), received between February 2018 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
341 reports arrived in the 12 months to August 2026, up 184% from 120 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (97.9%), injury (2%) and death (0.1%); across all stents, drains and dilators for the biliary ducts reports (product code FGE) death is recorded in 1.1% and malfunction in 69%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are burst container or vessel (36.2%), material puncture/hole (32.5%) and leak/splash (16%). The patient problems coded most often are no patient involvement, hemorrhage/blood loss/bleeding and perforation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 33,832 reports carrying product code FGE. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Burst container or vessel | 357 | 36.2% | 3.3% |
| Material puncture/hole | 320 | 32.5% | 3% |
| Leak/splashthe device leaked | 158 | 16% | 1.7% |
| Inflation problem | 102 | 10.4% | 1.6% |
| Tear, rip or hole in device packaging | 70 | 7.1% | 0.4% |
| Material split, cut or torn | 34 | 3.5% | 0.5% |
| Detachment of device or device componentpart of the device came off | 20 | 2% | 3.3% |
| Failure to deflate | 17 | 1.7% | 0.2% |
| Difficult to removethe device was hard to remove | 12 | 1.2% | 5.8% |
| Material integrity problema problem with the device material | 11 | 1.1% | 0.6% |
| Material twisted/bent | 11 | 1.1% | 1.1% |
| Deflation problem | 10 | 1% | 0.9% |
| Breakthe device broke | 8 | 0.8% | 9.7% |
| Difficult to advance | 8 | 0.8% | 1.5% |
| Material deformation | 6 | 0.6% | 3.9% |
| Entrapment of device | 5 | 0.5% | 1.1% |
| Packaging problem | 4 | 0.4% | 0.1% |
| Fluid/blood leak | 3 | 0.3% | 0.4% |
| Unsealed device packaging | 3 | 0.3% | 0.3% |
| Defective devicethe device was defective | 2 | 0.2% | 0.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 15 | 1.5% |
| Hemorrhage/blood loss/bleeding | 7 | 0.7% |
| Perforation | 6 | 0.6% |
| Respiratory insufficiency | 2 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Cholangitis | 1 | 0.1% |
| Cramp(s) /muscle spasm(s) | 1 | 0.1% |
| Laceration(s) | 1 | 0.1% |
| Pancreatitisinflammation of the pancreas | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cre Pro | Product code FGE | All MAUDE reports |
|---|---|---|---|
| Reports | 985 | 33,832 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 1 | 11 | 9 |
| Classified as injury | 2% | 29% | 36.2% |
| Classified as malfunction | 97.9% | 69% | 62.3% |
| Filed by the manufacturer | 96.6% | 97.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FGE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mustang | 5,969 | 491 | 0.3% |
| Hurricane RX | 1,227 | 51 | 0.2% |
| Advanix Biliary | 872 | 75 | 0.9% |
| WallFlex Biliary RX Stent System | 774 | 25 | 2.2% |
| Absolute Pro .035 Self Expanding Stent System | 858 | 38 | 0.2% |
| Zimmon Biliary Stent | 665 | 45 | 0% |
| Smart Control Nitinol Stent System | 1,438 | 0 | 1.7% |
| Evolution Biliary Controlled-Release Stent - Fully Covered | 600 | 99 | 0.2% |
| WallFlex Biliary | 834 | 56 | 1.8% |
| Zimmon Biliary Stent Set | 530 | 34 | 0% |
| Express LD Vascular | 520 | 47 | 0% |
| Extractor Rx Retrieval Balloon | 499 | 0 | 0.6% |
| Flexima Biliary | 485 | 34 | 0% |
| Zilver 635 Biliary Self Expanding Metal Stent | 362 | 13 | 0% |
| Express Vascular SD | 383 | 28 | 0.8% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Cre Pro reports
How many FDA reports name Cre Pro?
985 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 341 in the latest 12 months.
What kinds of events are reported?
malfunction (97.9%), injury (2%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
burst container or vessel (36.2%), material puncture/hole (32.5%), leak/splash (16%), inflation problem (10.4%) and tear, rip or hole in device packaging (7.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cre Pro was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.