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 2020-03-12 for LOCK PERICARDIOCENTESIS CATHETER SET N/A C-PCS-830-LOCK manufactured by Cook Inc.
[183354568]
(b)(6). Pma/510(k) #: exempt. 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
[183354569]
It was reported that a lock pericardiocentesis catheter set was selected for a pericardiocentesis procedure. Upon opening the package, the user found that the wire guide inside was kinked. The user then opened another package to complete the procedure. The device did not make patient contact. Upon preliminary analysis of the returned device, it was observed that the wire coating had flaked off in several spots on the distal curve where kinking was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00596 |
| MDR Report Key | 9823620 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2017-02-09 |
| Date Added to Maude | 2020-03-12 |
| 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 | MRS. 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 | LOCK PERICARDIOCENTESIS CATHETER SET |
| Generic Name | GBX CATHETER, IRRIGATION |
| Product Code | GBX |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-02-17 |
| Model Number | N/A |
| Catalog Number | C-PCS-830-LOCK |
| Lot Number | 7663654 |
| Device Expiration Date | 2020-02-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-12 |