MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for 201101 201101RR manufactured by Stryker Sustainability Solutions Phoenix.
[146680510]
The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, bends were identified 1cm and 67cm from the distal tip. The device did not meet the curve and planarity specifications. 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 continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[146680511]
It was reported that during the procedure the electrophysiology catheter did not curve properly. Instead of a c curve it looked like it was bent out of shape. The electrophysiology catheter was not deflecting enough. There was no patient injury, medical intervention, or extended procedure time reported. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002090040-2019-00014 |
| MDR Report Key | 8637435 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2019-01-24 |
| Date Added to Maude | 2019-05-23 |
| 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 | 2019-05-23 |
| Returned To Mfg | 2019-05-14 |
| Model Number | 201101 |
| Catalog Number | 201101RR |
| Lot Number | 3798031 |
| 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 | 2019-05-23 |