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 2020-01-15 for SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302 manufactured by The Spectranetics Corporation.
[175191736]
Patient weight unavailable.
Patient Sequence No: 1, Text Type: N, H10
[175191737]
A lead extraction procedure commenced to remove one right atrial (ra) lead due to non function. After the ra lead was successfully extracted, the patient's blood pressure dropped. Rescue efforts began immediately, including sternotomy. A superior vena cava (svc) injury was discovered. The physician repaired the injury and the patient survived the procedure. There was no reported malfunction with any spectranetics devices in use during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00013 |
| MDR Report Key | 9591297 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-15 |
| 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 14F GLIDELIGHT LASER SHEATH |
| Generic Name | GLIDELIGHT |
| Product Code | MFA |
| Date Received | 2020-01-15 |
| Model Number | 500-302 |
| Catalog Number | 500-302 |
| Lot Number | FGB19J21A |
| 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 | 2020-01-15 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-15 |