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 2020-03-25 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[186722828]
Device lot number and expiration date unavailable from the facility. Device manufacture date unavailable because device lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10
[186722829]
A lead extraction procedure commenced to remove two non functioning leads, one right atrial (ra) and one right ventricular (rv). The physician prepared both leads with a spectranetics lead locking device (lld) to act as a traction platform. A spectranetics tightrail rotating dilator sheath and spectranetics glidelight laser sheath were utilized to remove the leads. During the removal of the rv lead, traction was applied to the rv lead and at this time the patient's blood pressure dropped. Rescue efforts began immediately, including rescue device and sternotomy. A tear was identified at the right ventricle. Both leads were removed and the tear was repaired successfully. The patient survived the procedure. There was no alleged malfunction of any spectranetics devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00058 |
| MDR Report Key | 9879073 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-25 |
| 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. JESSICA DOMINGUEZ |
| 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 | 2020-03-25 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | UNAVAILABLE |
| 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 | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-25 |