MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for 10439236 UNK_SUS manufactured by Stryker Sustainability Solutions Phoenix.
[48097292]
The device was returned to stryker sustainability solutions for evaluation. The results of the investigation determined that the reported issue was not confirmed. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. The reported event could be attributed to: user error (including user technique and methods). Connection error (including the contact of the pins to the cable receptors or improper connection of the interconnect tab). Ancillary equipment error (including all other equipment outside of the complaint device that may have contributed to the error). User expectation / anticipation of device image. The instructions for use state: inspect the catheter for overall condition and physical integrity. Do not use the catheter if any damage is noted. If such problems exist, return the catheter and packaging to stryker sustainability solutions. For proper care and handling of the 3d diagnostic ultrasound catheter, always hold the ultrasound catheter by the handle and support the catheter shaft. Avoid touching the 3d diagnostic ultrasound catheter interconnect tab. Lift the lever on the connector, slipping it onto the catheter interconnect tab until fully mated with the steering handle. Push the lever down, locking into place. Use the hypertronic catheter connector to connect the 3d diagnostic ultrasound catheter to the mapping system. When the 3d diagnostic ultrasound catheter is used in conjunction with the carto xp mapping system, connect the catheter to the patient interface unit (piu) using a sterile extension cable (not provided by stryker sustainability solutions). For use of the 3d diagnostic ultrasound catheter in mapping procedures, an additional external reference patch (not provided by stryker sustainability solutions) is required for location reference position purposes. Connect the external reference patch (not provided by stryker sustainability solutions) following the appropriate mapping system documentation. The 3d diagnostic ultrasound catheters are connected to standard ultrasound equipment using appropriate connectors. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[48097293]
It was reported that while performing an emergency case, the device did not function when plugged in. After a couple attempts, another device was tried and the same issue occurred. Therefore, the procedure type was switched to transesophageal echocardiography (tee). The procedure was completed successfully and no additional anesthesia was required. Extended procedure time reported was minimal.
Patient Sequence No: 1, Text Type: D, B5
[48651585]
Through subsequent engineering, clinical and risk review, it was determined that the reported event was unrelated to the stryker sustainability solutions (sss) device based on review of the device investigation. The device met all specifications and review of both eeprom determined the device was not used, therefore root cause of the event points to customer connection error to the carto system for 3d mapping. It was determined that this event was not directly related to the functionality of an sss device. It was also determined that it is unlikely this event could cause or contribute to serious injury and/or death. This event does not meet the reporting requirements for an mdr.
Patient Sequence No: 1, Text Type: N, H10
[48651586]
It was reported that while performing an emergency case, the device did not function when plugged in. After a couple attempts, another device was tried and the same issue occurred. Therefore, the procedure type was switched to transesophageal echocardiography (tee). The procedure was completed successfully and no additional anesthesia was required. Extended procedure time reported was minimal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002090040-2016-00008 |
| MDR Report Key | 5746545 |
| Date Received | 2016-06-23 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-05-26 |
| Date Mfgr Received | 2016-05-26 |
| Device Manufacturer Date | 2016-03-08 |
| Date Added to Maude | 2016-06-23 |
| 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. MOIRA BARTON VARTY |
| 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 | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2016-06-23 |
| Returned To Mfg | 2016-06-07 |
| Model Number | 10439236 |
| Catalog Number | UNK_SUS |
| Lot Number | 2819845SH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-06-23 |