MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-05 for 401932 401932RR manufactured by Stryker Sustainability Solutions Phoenix.
[139180498]
The complaint device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, a kink was identified 4 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, including shipping and storage conditions, subsequent to distribution from stryker. The instructions for use (ifu) state: inspect the catheter for overall condition and physical integrity. Do not use the catheter if electrodes appear loose or if any damage is noted. If such problems exist, return the catheter and packaging to stryker sustainability solutions. Connect the catheter to the corresponding cable connector. Connect the cable to the correct electronic equipment for recording and/or sensing. Observe polarity of proximally located connector pins of the interface cable when connecting to the electronic equipment. Isolate any unused connector pins to reduce development of accidental current pathways to the heart. Follow a suitable electrophysiology study protocol. Do not autoclave catheter. Do not use for electrical ablation. Avoid excessive contact of handpiece with fluids, as this could adversely affect the electrical performance of the catheter. Diagnostic ep catheters are not recommended for long term pacing. The reported event will be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[139180499]
It was reported that during the case, the electrophysiology catheter became extremely bent and would not read properly. 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 | 0002090040-2019-00007 |
| MDR Report Key | 8392790 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-05 |
| Date of Report | 2019-03-05 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2018-09-28 |
| Date Added to Maude | 2019-03-05 |
| 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 |
| 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 | 2019-03-05 |
| Returned To Mfg | 2018-12-27 |
| Model Number | 401932 |
| Catalog Number | 401932RR |
| Lot Number | 3697512 |
| 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 | 2019-03-05 |