Devices › Biliary catheter for stone removal that may also allow for irrigation and contrast injection
Device brand name · Gca catheter biliary diagnostic catheter nephrostomy
Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter: medical device reports filed with FDA
250 reports name it, 2016–2026. Manufacturer given most often on reports: Cook. Product code GCA.
- 250
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 7
- reports, 12 months to August 2026
- 14 in the 12 months before
- 72.8%
- classified as malfunction
- 81.5% across the product code
- 1.2%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 250 reports that name the brand "Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter" (gca catheter biliary diagnostic catheter nephrostomy), received between July 2016 and July 2026; the manufacturer given most often on reports is Cook. Spellings of one product vary from report to report.
7 reports arrived in the 12 months to August 2026, down 50% from 14 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 (72.8%), injury (26%) and death (1.2%); across all biliary catheter for stone removal that may also allow for irrigation and contrast injection reports (product code GCA) death is recorded in 0.2% and malfunction in 81.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to remove (32.8%), leak/splash (13.6%) and material separation (10%). The patient problems coded most often are no patient involvement, foreign body in patient and death. 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 443 reports carrying product code GCA. 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 |
|---|---|---|---|
| Difficult to removethe device was hard to remove | 82 | 32.8% | 9.5% |
| Leak/splashthe device leaked | 34 | 13.6% | 8.1% |
| Material separation | 25 | 10% | 6.8% |
| Fluid/blood leak | 16 | 6.4% | 2.3% |
| Breakthe device broke | 14 | 5.6% | 7.2% |
| Difficult to advance | 12 | 4.8% | 2% |
| Detachment of device or device componentpart of the device came off | 11 | 4.4% | 1.4% |
| Device contaminated during manufacture or shipping | 9 | 3.6% | 0.9% |
| Failure to advance | 7 | 2.8% | 0.2% |
| Detachment of device component | 6 | 2.4% | 4.5% |
| Crackthe device cracked | 4 | 1.6% | 0.9% |
| Material twisted/bent | 4 | 1.6% | 0.5% |
| Component falling | 3 | 1.2% | 1.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 1.2% | 0.7% |
| Material deformation | 3 | 1.2% | 0.2% |
| Obstruction of flow | 3 | 1.2% | 0.5% |
| Unsealed device packaging | 3 | 1.2% | 0% |
| Device-device incompatibility | 2 | 0.8% | 0% |
| Difficult to insertthe device was hard to insert | 2 | 0.8% | 0.5% |
| Fitting problem | 2 | 0.8% | 0.2% |
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 | 9 | 3.6% |
| Foreign body in patientpart of a device left in the patient | 4 | 1.6% |
| Deaththe patient died; cause not stated by this term | 3 | 1.2% |
| Hemorrhage/blood loss/bleeding | 3 | 1.2% |
| Inflammationinflammation | 3 | 1.2% |
| Perforation | 2 | 0.8% |
| Abscessa collection of pus | 1 | 0.4% |
| Aneurysm | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
| Pleural effusionfluid around the lung | 1 | 0.4% |
| Pneumothoraxa collapsed lung | 1 | 0.4% |
| Sepsisa severe body-wide response to infection | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter | Product code GCA | All MAUDE reports |
|---|---|---|---|
| Reports | 250 | 443 | 26,136,888 |
| Share of that pool | — | 56.4% | 0% |
| Classified as death, per 1,000 reports | 12 | 2 | 9 |
| Classified as injury | 26% | 17.8% | 36.2% |
| Classified as malfunction | 72.8% | 81.5% | 62.3% |
| Filed by the manufacturer | 100% | 94.4% | 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 GCA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Extractor Rx Retrieval Balloon | 499 | 0 | 0.6% |
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 Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter reports
How many FDA reports name Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter?
250 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
malfunction (72.8%), injury (26%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (32.8%), leak/splash (13.6%), material separation (10%), fluid/blood leak (6.4%) and break (5.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ultrathane Mac-Loc Locking Loop Biliary Drainage Catheter 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.