FDA Adverse Event
Death
Summary report: N
SPNC LASER SHEATH/LEAD LOCKING DEVICE
MDR report key: 1696206
·
Received May 19, 2010
Report
- Report Number
- 1721279-2010-00022
- Event Type
- Death
- Date Received
- May 19, 2010
- Date of Event
- May 4, 2010
- Report Date
- May 18, 2010
- Manufacturer
- SPECTRANETICS CORPORATION
- Product Code
- MFA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER DATES FOR ALL DEVICES: UNK.
Description of Event or Problem · 1
INDICATION FOR PROCEDURE: CLASS I EROSION AND INFECTION; TEMPORARY PACER LEAD IN FEMORAL VEIN. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE THAT TOOK PLACE IN THE CARDIAC CATHETER LAB TO REMOVE A TOTAL OF 4 LEADS (1/RA & 3/RV). DURING THE REMOVAL OF A (B) (6) RA LEAD, THE PT'S ARTERIAL PRESSURE DROPPED. THE MD REQUESTED A TRANSESOPHAGEAL ECHOCARDIOGRAM, AN EFFUSION WAS NOTED AND DRAINED. THE CT SURGEON WAS CONTACTED AND 20 MINS LATER, THE PT WAS TRANSFERRED TO THE OPERATING ROOM FOR AN EMERGENT SURGICAL REPAIR OF THE ATRIUM. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT WERE REPORTED BY THE PHYSICIAN. PATIENT OUTCOME: DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPNC LASER SHEATH/LEAD LOCKING DEVICE | 14F SLS / LLD (UNK SIZE) | MFA | SPECTRANETICS CORPORATION | 500-012 / UNK | UNK / UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | GENERATION 4 EXCIMER LASER| VISISHEATH (43CM M) |