FDA Adverse Event
Injury
Summary report: N
CONVOY ADVANCED DELIVERY SHEATH
MDR report key: 1269738
·
Received December 17, 2008
Report
- Report Number
- 2953184-2008-00073
- Event Type
- Injury
- Date Received
- December 17, 2008
- Date of Event
- July 17, 2005
- Report Date
- November 17, 2008
- Manufacturer
- BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC
- Product Code
- DYB
- PMA / PMN Number
- K992309
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE WERE UNABLE TO PERFORM A PRODUCT ANALYSIS AS NO DEVICE WAS RECEIVED. THERE IS NO EVIDENCE THAT INDICATES THE DEVICE INVOLVED IN THIS EVENT MALFUNCTIONED, OR IN SOME WAY DID NOT PERFORM TO SPECIFICATION THAT MAY HAVE RESULTED IN THIS EFFECT. THE REPORTED EVENT IS A KNOWN/POSSIBLE PROCEDURAL COMPLICATION AND IS APPROPRIATELY LABELED AS AN ADVERSE EVENT WITHIN THE DIRECTIONS FOR USE. WE WERE UNABLE TO REVIEW MANUFACTURING RECORDS AS THE BATCH NUMBER IS UNKNOWN. A SIMILAR COMPLAINT TREND WAS REVIEWED FOR THIS PRODUCT FAMILY, AND NO ADVERSE TRENDS WERE IDENTIFIED.
Description of Event or Problem · 1
DURING A REVIEW OF INFO RELATED TO THE CRYOCOR CLINICAL TRIAL, WE DISCOVERED THAT THE PATIENT EXPERIENCED LYMPHEDEMA POST-PROCEDURE THAT WAS RESOLVED IN 2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONVOY ADVANCED DELIVERY SHEATH | DYB | BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |