MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-26 for 401582 401582RR manufactured by Stryker Sustainability Solutions Phoenix.
[131474826]
The device was not returned to stryker sustainability solutions for evaluation. Should the device become available for return, the investigation will be reopened. As the device was not returned to stryker sustainability solutions, evaluation was 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. Electrode 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: 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. Inspect the packaging and catheter for damage or defects prior to use. The reported event will be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[131474827]
It was reported that during an ablation for atrial fibrillation, the doctor observed a drop in the patient's blood pressure. After checking on intracardiac echo, the doctor noted a small pericardial effusion. He stated that he believed the effusion was due to a perforation in the coronary sinus when he had placed a catheter there earlier in the case (stryker livewire). The physician proceeded with the case and completed the procedure, leaving the coronary sinus catheter in place. Multiple attempts were made to obtain additional information. No information was provided. However, there was no 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 | 0002090040-2018-00018 |
| MDR Report Key | 8198130 |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2018-12-26 |
| 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 | 0 |
| Brand Name | NA |
| Generic Name | CATHETER, RECORDING, ELECTRODE, REPROCESSED |
| Product Code | NLH |
| Date Received | 2018-12-26 |
| Model Number | 401582 |
| Catalog Number | 401582RR |
| Lot Number | 3515632 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-12-26 |