FDA Adverse Event
Death
Summary report: N
SPECTRANETICS GLIDELIGHT LASER SHEATH
MDR report key: 3343338
·
Received September 11, 2013
Report
- Report Number
- 1721279-2013-00147
- Event Type
- Death
- Date Received
- September 11, 2013
- Date of Event
- August 15, 2013
- Report Date
- September 4, 2013
- Manufacturer
- SPECTRANETICS CORPORATION
- Product Code
- MFA
- PMA / PMN Number
- P960042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THIS WAS A LEAD EXTRACTION CASE TO REMOVE 3 RV LEADS FOR CIED POCKET INFECTION. THE FIRST TWO LEADS (RV PACING LEADS, MODELS UNKNOWN) WERE REMOVED SUCCESSFULLY UTILIZING A 14 FR. GLIDELIGHT. THE 14 FR WAS UTILIZED ON THE 3RD LEAD (GUIDANT 4474 RV ICD), THERE WAS RESISTANCE NEAR THE PROXIMAL COIL, SO HE UPSIZED TO A 16 FR. GLIDELIGHT. HE SLOWLY CONTINUED LASING TO THE DISTAL COIL NEAR THE TRICUSPID VALVE WHEN THE BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS SEEN ON TEE, A THORACOTOMY WAS PERFORMED, BUT THE OPERATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. THERE WAS AN INJURY AT THE INNOMINATE-SVC JCT / MID SVC / SVC-ATRIAL JUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456678 | SPECTRANETICS GLIDELIGHT LASER SHEATH | 16 FR. GLIDELIGHT | MFA | SPECTRANETICS CORPORATION | 500-303 | FGC13E01E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death | GUIDANT 4474 RV ICD LEAD| RV PACING LEADS (MODELS UNKNOWN) X 2| SPECTRANETICS LEAD LOCKING DEVICE (LLD #2) X 3| SPECTRANETICS 14 FR. GLIDELIGHT |