MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-10 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[180209570]
Date of birth unknown. Weight unknown.
Patient Sequence No: 1, Text Type: N, H10
[180209571]
A lead extraction procedure commenced for the extraction of a right ventricle (rv) and a right atrium (ra) lead due to infection. The rv and ra were implanted in 2006. Spectranetics lead locking devices and 14f glidelight were being used in the procedure. Progress had stalled on both of the lead attempts in the area of the subclavian vein due to adhesion. They then used a mechanical device manufactured by cook, and the lead began to stretch out. They removed the ra lead using a snare (manufacturer unknown) from the femoral access site. They then attempted to remove the rv lead also using the snare and lasing at the proximal end of the lead. It was then that they noticed bleeding had increased from the pocket and a cautery knife was used to obtain hemostasis in the area of the pocket, but it was not successful. They then discovered that there was a tear in subclavian vein and rescue interventions commenced. They repaired the injury to the subclavian by suturing. After the repair, the procedure continued and they removed the rv lead successfully using the snare. Patient survived the procedure. The physician mentioned that felt this event occurred due to either too much traction or too much peeling using the cautery knife.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00028 |
| MDR Report Key | 9687454 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-10 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-10 |
| 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 | MS. NICOLE WORFORD |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS LEAD LOCKING DEVICE |
| Generic Name | LLD |
| Product Code | DRB |
| Date Received | 2020-02-10 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | FLP19E01A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Product Code | --- |
| Date Received | 2020-02-10 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-10 |