FDA Adverse Event
Malfunction
Summary report: N
HS III PROXIMAL SEAL SYTEM 3.8MM
MDR report key: 3193320
·
Received June 25, 2013
Report
- Report Number
- 2242352-2013-00608
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Report Date
- June 6, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR,LLC
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THE HEARTSTRING III FAILED TO LOAD PROPERLY AS THE SEAL REMAINED INSIDE THE LOADER WHEN THE DELIVERY DEVICE WAS REMOVED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287544 | HS III PROXIMAL SEAL SYTEM 3.8MM | CLAMPLESS BEATING HEART | DXC | MAQUET CARDIOVASCULAR,LLC | HSK-3038 | 25074005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |