MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-01-06 for SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE G03460 THSCF-35-260-3-AES manufactured by Cook Inc.
[176052940]
Common name & product code = dqx wire, guide, catheter. Pma/510(k) number = pre-amendment. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[176052941]
As reported, a fray was observed to the tip of a cook safe-t-j amplatz extra-stiff support wire guide. The fray was observed prior to use. The device did not make patient contact. Another equivalent product was used to complete the unspecified peripheral vascular procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00055 |
| MDR Report Key | 9553087 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2019-12-25 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2020-01-06 |
| 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 | UNK JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2020-01-06 |
| Model Number | G03460 |
| Catalog Number | THSCF-35-260-3-AES |
| Lot Number | 9808526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |