MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC HS III PROXIMAL SEAL SYSTEM 3.8MM

Model Number HSK-3038

Device Problems Crack (1135); Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2013

Event Type  Injury  

Event Description

The hospital reported that during a coronary artery bypass procedure, blood leaked on a cracked heartstring iii seal and while pulling out of the device, the aorta was torn.There was a small amount of bleeding, but it wasn't serious, so the f/u measures were performed well.The overall condition of the pt's aorta was good.The diameter of the aorta was 27mm, with a little bit of calcification and the pt's mean blood pressure was 110mmhg.The operation was completed using a replacement device.The pt's current condition is good.The hospital did not report any add'l pt effects.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the eval is completed.A lot history record review was completed for the reported product lot number.There was no non-conformance recorded in the lot history.(b)(4).

• Brand Name: HS III PROXIMAL SEAL SYSTEM 3.8MM
• Type of Device: PROXIMAL SEAL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 3565325
• MDR Text Key: 4075328
• Report Number: 2242352-2013-01853
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: HSK-3038
• Device Lot Number: 25083458
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 53