FDA Adverse Event
Malfunction
Summary report: N
HEARTSTRING III PROXIMAL SEAL SYSTEM, 4.3 MM
MDR report key: 1760966
·
Received July 14, 2010
Report
- Report Number
- 2242352-2010-01888
- Event Type
- Malfunction
- Date Received
- July 14, 2010
- Date of Event
- May 20, 2010
- Report Date
- June 15, 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
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON (B)(4), 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, "IT WAS IMPOSSIBLE FOR THE SURGEON TO DEPLOY THE HEARTSTRING SEAL; THERE WAS SOMETHING WRONG WITH THE RELEASE MECHANISM OF THE HEARTSTRING." A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP REPORTED NO PT EFFECTS. THE PRODUCT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTRING III PROXIMAL SEAL SYSTEM, 4.3 MM | PROXIMAL SEAL | DXC | MAQUET CARDIOVASCULAR, LLC | HSK-3043 | 25005572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |