MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-10-13 for HS III PROXIMAL SEAL SYSTEM 4.3MM HSK-3043 NA manufactured by Maquet Cardiovascular, Llc.
[2340119]
The hospital reported that during a coronary artery bypass procedure, three heartstring iii malfunctioned. The first did not fire, the second did not deploy and the third did not remain in the aorta after being fired. A replacement unit was used to complete the procedure. The hospital did not report any pt effects. Maquet cardiovascular anticipates the return of the product in question. Refer to 2242352-2011-01525 and 2242352-2011-01527.
Patient Sequence No: 1, Text Type: D, B5
[9375224]
The device has not yet 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 if the device is rec'd. A lot history record review was completed for the reported product lot number. There were no non conformance issue(s) with this production lot. Internal file number - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242352-2011-01526 |
| MDR Report Key | 2315151 |
| Report Source | 05,07 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-10-10 |
| Date of Event | 2011-10-07 |
| Date Mfgr Received | 2011-10-10 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-07-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRIAN BEACHUM |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097690 |
| Manufacturer G1 | MAQUET CARDIOVASCULAR, LLC |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HS III PROXIMAL SEAL SYSTEM 4.3MM |
| Generic Name | CLAMPLESS BEATING HEART |
| Product Code | DQD |
| Date Received | 2011-10-13 |
| Model Number | HSK-3043 |
| Catalog Number | NA |
| Lot Number | 25038635 |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOVASCULAR, LLC |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-13 |