MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE NT4W22115 manufactured by Gyrus Acmi, Inc.
[86009391]
At the time of this report, the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
[86009392]
The device got stuck around a stone in the ureter. The ureter was large enough to extract the stone, but then the ostium appeared to be too small. Ultra catch sat around the stone and did not come loose anymore. Loosen at the end of the handle and pulled the sleeve off, but the wires of the basket did not loosen themselves. And stayed around the stone. Swapped from flex scoop to semi rigid and making with the lithoclast the stone smaller. Then the last part could be removed ultra catch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011050570-2017-00007 |
| MDR Report Key | 6856423 |
| Date Received | 2017-09-11 |
| Date of Report | 2018-01-15 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2017-09-11 |
| 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 TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE |
| Generic Name | STONE RETRIEVAL DEVICE |
| Product Code | FGO |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-08-25 |
| Model Number | NT4W22115 |
| Lot Number | MK915810 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-11 |