MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC PROXIMAL SEAL SYSTEM 3.8MM; ENDOSCOPIC VESSEL HARVESTING

Model Number HSK-3038

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, the heartstring iii failure to load properly.A replacement device was used to complete the procedure.The hospital did not report any pt effects.There was no pt contact.

Manufacturer Narrative

The device was returned to the factory for eval.It showed no signs of clinical usage.There was evidence of blood.The delivery device was returned outside the loading device.The tension spring assembly, anchor tab and the seal were returned outside the devices.The green slide lock and the white plunger were not depressed on the delivery device.Based upon the eval results, the reported complaint was confirmed for failure to load.A lot history record review was completed for the reported product lot number.There was no non-conformance recorded in the lot history.Internal corrective action (wy-2013-35) issued for this failure mode.(b)(4).

• Brand Name: PROXIMAL SEAL SYSTEM 3.8MM
• Type of Device: ENDOSCOPIC VESSEL HARVESTING
• 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: 3871279
• MDR Text Key: 4592438
• Report Number: 2242352-2014-00430
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: HSK-3038
• Device Lot Number: 25076144
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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