FDA Adverse Event
Injury
Summary report: N
JOSTENT GRAFTMASTER
MDR report key: 1063446
·
Received June 19, 2008
Report
- Report Number
- 2024168-2008-00508
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 21, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- HDE00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION/PERMANENT DAMAGE/HOSPITALIZATION. REPORTING RATIONALE: FAILURE TO CROSS REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT THE GRAFTMASTER DEVICE FAILED TO CROSS TO TREAT A PERFORATION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PT EXPERIENCED PERICARDIAL EFFUSION AND RESPIRATORY DISTRESS, AND WAS TREATED WITH CPR AND INTUBATED. THE PT DID NOT DIE. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOSTENT GRAFTMASTER | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 505764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R| S |