MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-06-26 for N-COMPASS NITINOL STONE EXTRACTOR N/A C-NTSE-2.4-115-NC3 manufactured by Cook Vascular Inc.
[78389989]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[78389990]
International customer reported that a patient was scheduled to undergo a choledochotomy using a n-compass nitinol stone extractor. The user found that the outer sheath of the device nearby the handle end was broken. The event was noted prior to use during procedural preparation. Photos supplied by the customer show a severing of the catheter sheath just distal to the flare. A replacement device was used to complete the procedure. There are no reported adverse patient consequences. The device is available for evaluation, however it has not been received by the manufacture as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01475 |
| MDR Report Key | 6666939 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-06-26 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2017-11-16 |
| Device Manufacturer Date | 2016-11-08 |
| Date Added to Maude | 2017-06-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N-COMPASS NITINOL STONE EXTRACTOR |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2017-06-26 |
| Model Number | N/A |
| Catalog Number | C-NTSE-2.4-115-NC3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK VASCULAR INC |
| Manufacturer Address | 1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-26 |