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 2020-02-06 for SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302 manufactured by The Spectranetics Corporation.
[178014807]
Patient's date of birth unavailable. Patient's weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable because lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10
[178014808]
A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to this patient not requiring the device/leads any longer, and the patient requested extraction. The physician noted this was a difficult case, with significant calcium and scar tissue present on the leads. Beginning with a spectranetics 14f glidelight laser sheath and medium visisheath, the case proceeded. Due to stalled progress, the physician used an 11f tightrail sub-c device, then back to the glidelight device, then to an 11f tightrail device. The physician went back and forth between the ra and rv leads in order to progress. It was reported that both leads were extracted. However, at the time the rv lead was removed and the glidelight device was removed along with the lead, the patient's blood pressure dropped. Rescue efforts began immediately. However, during rescue and while the team attempted to identify the issue, the patient's heart stopped and cpr began. Other rescue efforts were then attempted, but the patient went into ventricular fibrillation (vf) and died. The cardiothoracic surgeon arrived and a sternotomy was not performed. However, the physician feels there was an injury in the superior vena cava (svc)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00024 |
| MDR Report Key | 9677797 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-03 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | 500-302 |
| Catalog Number | 500-302 |
| Lot Number | UNAVAILABLE FROM FACILITY |
| 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 | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-06 |