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 2020-03-10 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[184074553]
Device lot number, expiration date unavailable. Device manufacture date unavailable because device lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[184074554]
A lead extraction procedure commenced to extract two leads: right atrial (ra) lead and a right ventricular (rv) lead due to high impedence. The patient was dependent on a pacemaker. Spectranetics lead locking devices (ldl's) were used in each lead to act as a traction platform. After both leads had been successfully extracted, the patient's blood pressure started to drift slowly downward. The surgeon was notified and the operating room was set up for surgery. The team monitored the patient for over an hour, with the patient's blood pressure continuing to slowly drop. Rescue efforts began, including rescue device and pericardiocentesis using a pigtail catheter. There was a blood return (they did not measure), but the physician discovered that a hole was created from the use of the pigtail catheter, into the rv apex. At that time, the surgeon performed a sternotomy; the repair to the rv apex was successful and the patient survived the procedure. It is thought that traction may have caused/contributed to an injury in the rv (the spectranetics lld was used as the traction platform); however this was not confirmed and no further intervention to the rv area was performed/required, other than the rv apex repair done by the surgeon, which was created by the pigtail catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00049 |
| MDR Report Key | 9811239 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-17 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-10 |
| 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 LEAD LOCKING DEVICE |
| Generic Name | LLD |
| Product Code | DRB |
| Date Received | 2020-03-10 |
| 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 | 2020-03-10 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-10 |