MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-04 for STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE C-DOC-35-50-0-3 manufactured by Cook Inc.
[177840315]
Initial reporter? Customer (person): email- (b)(6). Occupation: purchasing manager. Pma/510(k): preamendment. 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
[177840316]
It was reported that a straight and curved double flexible tipped wire guide unraveled while inside the patient. An (b)(6) year old female patient was initially admitted to the hospital on (b)(6) 2020 after a robotic assisted left lower lobectomy with a lymph node biopsy. She was transferred to a med surgical bed post operation. The central line was placed in the patient's left subclavian on (b)(6) 2020. Upon insertion, the guide wire was not threading smoothly. The physician pulled the wire back and found it to be unravelling. A new guide wire was used to complete the procedure. No adverse effects to the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00286 |
| MDR Report Key | 9667454 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-02-19 |
| Date Added to Maude | 2020-02-04 |
| 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 | STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2020-02-04 |
| Model Number | NA |
| Catalog Number | C-DOC-35-50-0-3 |
| Lot Number | 9474508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-04 |