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 |