MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-29 for DIAMOND-EDGE DISPOSABLE AORTIC PUNCH DP-52K manufactured by Teleflex Medical.
[129056094]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[129056095]
It was reported that the arterial punch was applied twice. It would not release the second time. Then the handle came off. There was small damage to the artery but not critical according to the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00354 |
| MDR Report Key | 8116339 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2018-11-29 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMOND-EDGE DISPOSABLE AORTIC PUNCH |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOV |
| Product Code | DWS |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2018-12-07 |
| Catalog Number | DP-52K |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |