Devices › Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
Device brand name · Endovascular arteriovenous fistula device
WavelinQ 4FR P: medical device reports filed with FDA
191 reports name it, 2021–2026. Manufacturer given most often on reports: Clearstream Technologies. Product code PQK.
- 191
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 35
- reports, 12 months to August 2026
- 32 in the 12 months before
- 50.8%
- classified as malfunction
- 55.3% across the product code
- 3.1%
- classified as death, as reported
- 6 reports · not verified by FDA
191 medical device reports received by FDA name the brand "WavelinQ 4FR P" (endovascular arteriovenous fistula device); the manufacturer given most often on reports is Clearstream Technologies; received from January 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
35 reports arrived in the 12 months to August 2026, close to the 32 of 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 (50.8%), injury (46.1%) and death (3.1%); across all percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access reports (product code PQK) death is recorded in 1.4% and malfunction in 55.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material deformation (25.7%), failure to cut (16.2%) and break (12%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, stenosis and thrombosis/thrombus. 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 488 reports carrying product code PQK. 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 |
|---|---|---|---|
| Material deformation | 49 | 25.7% | 21.7% |
| Failure to cut | 31 | 16.2% | 16.6% |
| Breakthe device broke | 23 | 12% | 6.6% |
| Activation problem | 16 | 8.4% | 7.8% |
| Device dislodged or dislocated | 13 | 6.8% | 4.9% |
| Device-device incompatibility | 5 | 2.6% | 1.8% |
| Difficult to removethe device was hard to remove | 4 | 2.1% | 3.3% |
| Stretched | 4 | 2.1% | 1.2% |
| Device damaged prior to usethe device was damaged before use | 3 | 1.6% | 1.4% |
| Difficult to advance | 3 | 1.6% | 2% |
| Failure to align | 3 | 1.6% | 9.8% |
| Improper or incorrect procedure or method | 3 | 1.6% | 0.8% |
| Insufficient device problem information | 3 | 1.6% | 0.6% |
| Restricted flow rate | 3 | 1.6% | 0.6% |
| Device contamination with chemical or other material | 2 | 1% | 0.4% |
| Packaging problem | 2 | 1% | 0.4% |
| Failure to advance | 1 | 0.5% | 0.4% |
| Material twisted/bent | 1 | 0.5% | 1% |
| Peeled/delaminated | 1 | 0.5% | 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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 71 | 37.2% |
| Stenosis | 50 | 26.2% |
| Thrombosis/thrombus | 10 | 5.2% |
| Restenosis | 6 | 3.1% |
| Swelling/ edema | 6 | 3.1% |
| Cardiac arrestthe heart stopped | 2 | 1% |
| Obstruction/occlusion | 2 | 1% |
| Painpain, site not specified | 2 | 1% |
| Bradycardiaslow heart rate | 1 | 0.5% |
| Bruise/contusion | 1 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.5% |
| Infiltration into tissue | 1 | 0.5% |
| Ischemia | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WavelinQ 4FR P | Product code PQK | All MAUDE reports |
|---|---|---|---|
| Reports | 191 | 488 | 26,136,888 |
| Share of that pool | — | 39.1% | 0% |
| Classified as death, per 1,000 reports | 31 | 14 | 9 |
| Classified as injury | 46.1% | 43.2% | 36.2% |
| Classified as malfunction | 50.8% | 55.3% | 62.3% |
| Filed by the manufacturer | 100% | 99% | 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."
Questions about WavelinQ 4FR P reports
How many FDA reports name WavelinQ 4FR P?
191 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 35 in the latest 12 months.
What kinds of events are reported?
malfunction (50.8%), injury (46.1%) and death (3.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (25.7%), failure to cut (16.2%), break (12%), activation problem (8.4%) and device dislodged or dislocated (6.8%). 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 WavelinQ 4FR P 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.