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 UNAVAILABLE manufactured by The Spectranetics Corporation.
[184075408]
Patient weight is unavailable from the facility. Device lot number, catalog number, expiration date and udi unavailable from the facility. Device manufacture date unavailable because device lot number unavailable. 510k# unavailable without model number.
Patient Sequence No: 1, Text Type: N, H10
[184075409]
A lead extraction case commenced to remove three leads, two right ventricular (rv) and one right atrial (ra), due to bacteremia and pocket infection. All three of the leads were prepared with a spectranetics lead locking device (lld) to act as a traction platform in the extraction attempts. A spectranetics glidelight laser sheath and a tightrail rotating dialator sheath was utilized to remove the leads. During the removal of the rv lead, traction was applied to the rv lead and at this time the patient's blood pressure dropped. Rescue efforts began immediately, including rescue device and sternotomy. A tear was identified at the superior vena cava (svc). The patient was placed on pump, the tear successfully repaired, and the patient survived the procedure. Follow up information from the philips representative at the case stated that the physician believes the rv lead had been adhered to the wall of the svc due to adhesions. When traction was applied to the rv lead, the rv lead was removed from the wall of the svc, causing a tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00053 |
| MDR Report Key | 9842137 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-25 |
| 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 | UNAVAILABLE |
| Catalog Number | UNAVAILABLE |
| 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 | 2020-03-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-17 |