MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-03 for COPILOT BLEEDBACK CONTROL VALVE 1003331 manufactured by Av-temecula-ct.
[144003606]
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional copilot device is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[144003607]
It was reported that two copilot bleed back control valves (bbcv) were leaking at the cap after an unspecified device was advanced through them. The procedure was successfully completed with a new copilot bbcv. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2019-03528 |
| MDR Report Key | 8579003 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-03 |
| Date of Report | 2019-07-10 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2019-01-01 |
| Date Added to Maude | 2019-05-03 |
| 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 | CONNIE SPECK |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
| Manufacturer Street | ABBOTT VASCULAR 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPILOT BLEEDBACK CONTROL VALVE |
| Generic Name | HEMOSTATIC VALVE |
| Product Code | DTL |
| Date Received | 2019-05-03 |
| Catalog Number | 1003331 |
| Lot Number | 60165724 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AV-TEMECULA-CT |
| Manufacturer Address | ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |