MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.
[183769199]
Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10
[183769200]
(this event was communicated to a philips employee on 20 feb 2020 by the physician/facility; however the procedure date was reported to be (b)(6) 2020). A lead extraction procedure commenced to remove a right ventricle (rv) and a right atrial (ra) due to non-function and occlusion. During the procedure, the rv lead was extracted successfully. During the attempt to remove the ra lead, the physician was using a spectranetics glidelight laser sheath. During lead removal attempt, it was discovered that an injury to the superior vena cava (svc) had occurred. Rescue intervention commenced immediately, including sternotomy. Despite rescue efforts, the patient did not survive the procedure. There was no reported malfunction of any spectranetics devices in use during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00055 |
| MDR Report Key | 9843321 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-23 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-17 |
| 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 16F GLIDELIGHT LASER SHEATH |
| Generic Name | GLIDELIGHT |
| Product Code | MFA |
| Date Received | 2020-03-17 |
| Model Number | 500-303 |
| Catalog Number | 500-303 |
| Lot Number | FGC19H09A |
| 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 | 2020-03-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-17 |