MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-01-15 for 401932 401932RR manufactured by Stryker Sustainability Solutions Phoenix.
[182707025]
The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, bends were identified at 2 cm and 14 cm from the distal tip of the device. The device did not meet the curve nor planarity specification. 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
[182707026]
It was reported that the electrophysiology catheter steering mechanism failed and the doctor had difficulty removing the device from the patient's body. The catheter was stuck in the patient's heart and was not deflecting. Two additional physicians and two additional devices were required to remove the electrophysiology catheter. There was a delay in the case of approximately 45 minutes to remove and replace the device. The patient was fine and there was no patient injury. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002090040-2020-00001 |
| MDR Report Key | 9591071 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Returned To Mfg | 2019-12-30 |
| Model Number | 401932 |
| Catalog Number | 401932RR |
| Lot Number | 4025136 |
| 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 | 2020-01-15 |