MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-21 for 401932 401932RR manufactured by Stryker Sustainability Solutions Phoenix.
[139178168]
The device was not returned to stryker sustainability solutions for evaluation. As the device was not returned for evaluation, visual and functional inspections were unable to be performed. A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker. Therefore the most likely root causes are: user improperly manipulates catheter and/or guiding sheath. Catheter shaft damage caused by mishandling/improper storage. Poor fit of components or component damage causes user to exert excessive force inserting device (e. G. Kinks, bends, electrode damage, cuts) 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. Should the device become available for return, the investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[139178169]
It was reported that an electrophysiology catheter was kinked, and the kink had to be manipulated to remove the device from the patient's body. There was no patient injury or medical intervention and extended procedure time reported was approximately one minute. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002090040-2019-00005 |
| MDR Report Key | 8357834 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2019-02-21 |
| 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 | 2019-02-21 |
| Model Number | 401932 |
| Catalog Number | 401932RR |
| Lot Number | 3727926 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-21 |