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 2020-02-11 for SPECTRANETICS LEAD LOCKING DEVICE UNKNOWN manufactured by The Spectranetics Corporation.
[180209952]
Device model number, lot number, expiration date and udi unavailable. 510k number unavailable because device model number unavailable. Device manufacture date unavailable because lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10
[180209953]
A lead extraction procedure commenced to remove three leads: a right atrial (ra) lead, a right ventricular (rv) lead and a left ventricular (lv) lead due to infection. Each lead was prepped with a spectranetics lead locking device (lld) to provide traction. The physician began by using a 16f glidelight laser sheath and successfully extracted the rv and ra leads. The team performed a coronary sinus (cs) venogram and then proceeded to remove the lv lead using 12f and 16f glidelight devices. The procedure was then completed, with the patient closed and extubated. However, shortly afterward, the patient's heart rate dropped and rescue efforts commenced immediately, including cpr. The patient was re-intubated and a pericardiocentesis was performed, removing a total of 350cc fluid. The patient survived the procedure, and was transferred to the cardiac icu. The patient's chest was never opened; the pericardiocentesis was the only intervention to treat the effusion. The physician believed that as a result of traction in the coronary sinus, an injury occurred, likely in the coronary sinus. Injury location was never confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00032 |
| MDR Report Key | 9696002 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-11 |
| 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 | 2020-02-11 |
| Model Number | UNKNOWN |
| 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 | 2020-02-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-11 |