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 2020-03-17 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.
[184075656]
A lead extraction case commenced to remove a non-functional right ventricle (rv) lead. A right atrial (ra) lead was also present in the patient but was not targeted for extraction. During preparation to removed the lead, a spectranetics lead locking device (lld) was placed inside the rv lead as a traction platform. Spectranetics tightrail rotating dilator sheath was in use in the innominate region and a glidelight laser sheath was in use in the subclavian region to aid in extraction. The physician then chose to use a cook medical byrd sheath to release lead on lead binding in the superior vena cava (svc) region. At the time the physician was using the cook byrd sheath, the patient's blood pressure dropped. Rescue efforts began immediately, including rescue device and sternotomy. Perforations were identified in the superior vena cava (svc) and right atrial (ra) junction. The perforations were repaired successfully, and the patient survived the procedure. During the repair, the physician attempted to unlock and remove the lld. When the attempt to unlock the lld was unsuccessful, the lld and rv lead was cut, capped, and left within the patient's body. This report is being submitted to capture this lld device. No spectranetics devices were reported to have caused or contributed to the patient injuries mentioned above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00050 |
| MDR Report Key | 9843743 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| 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. JESSICA DOMINGUEZ |
| 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 | 2020-03-17 |
| Model Number | 518-062 |
| Catalog Number | 518-062 |
| Lot Number | FLP19H28A |
| 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. Required No Informationntervention | 2020-03-17 |