MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-07-06 for LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET LR-PPLBES-8.5 manufactured by Cook Vascular Inc.
[48838799]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[48838800]
During extraction of ra and lv lead due to lead defect and incomplete pacing on a (b)(6) male patient, easy extraction of ra lead was performed. However, difficult extraction of lv lead with cook byrd dilator 8,5 and cook liberator locking stylet. Dilatation of cs with byrd to approximately. 2 cm before tip of lv. With massive pulling, the lead come out in total, but caused massive blood pressure drop. Injection of contrast medium showed fissured lv vein. With balloon dilatation, bleeding could be stooped. Heart lung machine was connected. With a covered stent, the dissected region was masked and bleeding stopped. Due to the use of the heart lung machine, the anesthesia gave 10. 000 units of heparin. Furthermore another manufacturers catheter was entered to the v. Jugularis. After hours, a total number of 21-23 blood preservation and the heparin caused a problematic deranged coagulation. There was no way to stop the bleeding, even at the other manufacturer's catheter entry and the patient died.
Patient Sequence No: 1, Text Type: D, B5
[53798036]
(b)(4). Investigation/evaluation: during the course of the investigation, a review of the complaint history and instructions for use (ifu) of the product was conducted. The device was not returned for evaluation. In addition, no photos of the device were provided and the lot number was not returned. As such, a full complaint investigation cannot be performed. However, based on the information provided a sheath was used in a lead extraction procedure in which a patient began bleeding after removal of the pacemaker lead and died after surgical intervention was attempted. Design documentation was reviewed and compared to the event description. There were not any comments made indicating that the device damaged the vessel or cardiac wall, contained a nonconformity, or was misused. There were not any other devices reportedly used in this procedure. The ifu contains warnings about the risks of the lead extraction process. There are no signs that the device did not perform as expected. In addition, there was not any information provided that suggested this procedure was undertaken or the device contained a nonconformity that increased the risk of patient death. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[53798037]
During extraction of ra and lv lead due to lead defect and incomplete pacing on a (b)(6) male patient, easy extraction of ra lead was performed. However, difficult extraction of lv lead with cook byrd dilator 8,5 and cook liberator locking stylet. Dilatation of cs with byrd to approximately. 2 cm before tip of lv. With massive pulling, the lead come out in total, but caused massive blood pressure drop. Injection of contrast medium showed fissured lv vein. With balloon dilatation, bleeding could be stooped. Heart lung machine was connected. With a covered stent, the dissected region was masked and bleeding stopped. Due to the use of the heart lung machine, the anesthesia gave 10. 000 units of heparin. Furthermore another manufacturers catheter was entered to the v. Jugularis. After hours, a total number of 21-23 blood preservation and the heparin caused a problematic deranged coagulation. There was no way to stop the bleeding, even at the other manufacturer's catheter entry and the patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00640 |
| MDR Report Key | 5771908 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-07-06 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-17 |
| Date Facility Aware | 2016-06-17 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-07-06 |
| 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. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET |
| Generic Name | GCC DILATOR, CATHETER |
| Product Code | GCC |
| Date Received | 2016-07-06 |
| Model Number | NA |
| Catalog Number | LR-PPLBES-8.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK VASCULAR INC |
| Manufacturer Address | 1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-07-06 |