MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-12 for 401932 401932RR manufactured by Stryker Sustainability Solutions Phoenix.
[130056614]
The complaint device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, a kink was identified 0. 5 cm from the distal tip which is distal to the transition point. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. The most likely root cause is mishandling subsequent to distribution, including shipping/storage conditions or improper manipulation of the catheter. The instructions for use (ifu) state: do not introduce the tip folded into the guiding sheath. Do not exert excessive pressure during placement of catheter if unknown resistance is encountered. Do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use. Avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters. The reported event will be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[130056615]
It was reported the tip of the electrophysiology catheter became bent during the procedure. There was no patient injury or medical intervention and extended procedure time reported was 5 minutes. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002090040-2018-00017 |
| MDR Report Key | 8155120 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2018-07-17 |
| Date Added to Maude | 2018-12-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARISSA RICHMOND |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS PHOENIX |
| Manufacturer Street | 10232 S. 51ST ST. |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CATHETER, RECORDING, ELECTRODE, REPROCESSED |
| Product Code | NLH |
| Date Received | 2018-12-12 |
| Returned To Mfg | 2018-10-05 |
| Model Number | 401932 |
| Catalog Number | 401932RR |
| Lot Number | 3629076 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS PHOENIX |
| Manufacturer Address | 10232 S. 51ST ST. PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |