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 2020-02-07 for LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET G23746 LR-EVN-11.0-RL manufactured by Cook Vandergrift Inc.
[178172647]
Product code: dre. Concomitant medical products: liberator locking stylet lr-ofa01, lr-ote-n, lr-evn-sh-9. 0-rl. Occupation: customer contact occupation: physician. Pma/510(k): k141148. Type of investigation not yet determined (4118). (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available or upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[178172648]
Dr. (b)(6) stated he would like to report an adverse event happened after use of evolution rl during lead extraction. After successful explanation with lr-evn-rl 11fr. And wound closure, blood pressure drop, trans-esophageal echocardiogram (tee) was performed which revealed excessive fluid accumulation around the heart consistent with cardiac tamponade, drainage was not successful. Thoracotomy immediately performed and the perforation of the heart wall was sutured successfully. Everything was stable, while closing the wound, however, patient died because of excessive blood loss and weak heart. Dr. (b)(6) is aware that any other procedure could have caused this complication. He doesn't blame our device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-2020-00011 |
| MDR Report Key | 9682072 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-10-30 |
| Date Added to Maude | 2020-02-07 |
| 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 | MR. BRIAN JOHNSTON |
| Manufacturer Street | 1186 MONTGOMERY LANE |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal | 15690 |
| Manufacturer Phone | 7248458621 |
| Manufacturer G1 | COOK VANDERGRIFT INC |
| Manufacturer Street | 1186 MONTGOMERY LANE |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET |
| Generic Name | VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-02-07 |
| Model Number | G23746 |
| Catalog Number | LR-EVN-11.0-RL |
| Lot Number | N167589 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK VANDERGRIFT INC |
| Manufacturer Address | 1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-07 |