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 2020-01-29 for SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302 manufactured by The Spectranetics Corporation.
[177008957]
Patient weight unavailable. Device lot number and expiration date unavailable from facility. Device manufacturer date unavailable because device lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[177008958]
A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead, and a right ventricular (rv) lead due to a bacterial infection. The physician successfully removed the ra lead without complications. A spectranetics 14f glidelight laser sheath was advanced over the rv lead to the area which appeared to be the right atrium. At that time, the patient's blood pressure dropped, and an effusion was noted using transesophageal echocardiography (tee). Rescue efforts commenced immediately, including rescue device, chest compressions and sternotomy. The patient's chest was opened within 4 minutes, and a tear was identified in the inferior vena cava (ivc). The repair to the injury was swift and successful; the rv lead was removed after the sternotomy; significant calcifications were noted in the right atrium, which the physician felt was possibly due to too much slack in rv lead at the time of implantation. The physician was not sure whether lasing or traction forces caused the tear in the ivc. The cardiothoracic surgeon who repaired the tear stated the lead was very calcified, and he thinks the ivc would have torn, no matter how the lead was removed. The patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00019 |
| MDR Report Key | 9644686 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-02 |
| Date of Event | 2020-01-02 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| 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 | 2020-01-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-29 |