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 2020-01-17 for SPECTRANETICS GLIDELIGHT LASER SHEATH UNKNOWN manufactured by The Spectranetics Corporation.
[176430624]
Patient weight unavailable. Deice model number, lot number, expiration date and udi unavailable. Device manufacture date unavailable because lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[176430625]
A lead extraction procedure commenced to remove 2 leads: a right atrial (ra) lead and a right ventricular (rv) lead due to bacteremia. The representative for the account in which the event occurred did not attend the procedure. The physician used a spectranetics glidelight laser sheath and lead locking devices (lld) which was placed inside each of the leads to provide traction. One of the leads was successfully removed without complication. During the attempt to remove the second lead, a superior vena cava (svc) tear was discovered via sternotomy. The repair to the svc was successful and the patient survived the procedure. There was no reported malfunction with any spectranetics devices in use during the procedure. The physician felt that the svc tear was as a result of lasing utilizing the glidelight device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00017 |
| MDR Report Key | 9604375 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-12-23 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-24 |
| Date Added to Maude | 2020-01-17 |
| 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 | 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 GLIDELIGHT LASER SHEATH |
| Generic Name | GLIDELIGHT |
| Product Code | MFA |
| Date Received | 2020-01-17 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| 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 | 2020-01-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-17 |