FDA Adverse Event
Malfunction
Summary report: N
HERTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
MDR report key: 1934545
·
Received November 23, 2010
Report
- Report Number
- 2242352-2010-03396
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 25, 2010
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL MISFIRED. AFTER A FOLLOW UP CONVERSATION, IT WAS REPORTED THAT MOST LIKELY THERE WAS AN ERROR IN SEAL LOADING. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT IS RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HERTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM | PROXIMAL SEAL | DXC | MAQUET CARDIOVASCULAR, LLC | HSK-3038 | 25014489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |