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 2020-02-12 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[178777339]
A lead extraction procedure commenced to remove two right ventricle (rv) leads, one of which was capped, a right atrium (ra) lead, and a left ventricle lead (lv) due to occlusion. When the physician was using the spectranetics 14f glidelight laser sheath on the capped rv lead to extract it, the patient's blood pressure dropped. Rescue interventions then commenced. A sternotomy was performed and a superior vena cava/right atrium (svc/ra) tear was discovered and attempted to be repaired. Rescue interventions were not successful and the patient expired. No leads were removed during the procedure. The physician believes that while lasing on the lead, the glidelight device jumped forward, causing the injury. However there was no alleged malfunction of the glidelight device, nor any other spectranetics devices used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00031 |
| MDR Report Key | 9700113 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| 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 | 2020-02-12 |
| 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. BARBARA CREEL |
| 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 | 2020-02-12 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | FLP19G08A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-12 |