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 2020-02-06 for SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302 manufactured by The Spectranetics Corporation.
[180209325]
A lead extraction procedure commenced to remove leads in the right ventricle (rv), right atrium (ra), and 2 in the left ventricle (lv), due to bacteremia. The rv, ra, and one lv lead were extracted successfully. The last lv lead was being extracted with a spectranetics 14f glidelight laser sheath; however it was reported that it was difficult to follow the path of the lead, but still removed successfully and subsequent to the extraction of all the leads, a transesophageal echocardiogram (tee) was performed. The tee showed an effusion and then the patients blood pressure dropped. Rescue intervention commenced and a pericardiocentesis was performed with no success. It was then that they performed a sternotomy in order to find out where the bleeding was coming from. It was discovered that there was a tear in the coronary sinus and it was repaired successfully. The patient received 4 units of blood during the procedure. The patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00027 |
| MDR Report Key | 9676657 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-06 |
| 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. NICOLE WORFORD |
| 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 | 2020-02-06 |
| Model Number | 500-302 |
| Catalog Number | 500-302 |
| Lot Number | FGB19D12A |
| 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 | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-06 |