MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

Catalog Number C-HSK-3038

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital reported that during a coronary artery bypass procedure, the aortic punch device malfunctioned and came out too far.The hospital did not report any patient effects.

Manufacturer Narrative

Updated: pt identifier, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative.The device was returned to the factory for evaluation.There were signs of clinical use and evidence of blood.The safety lock was disengaged and the actuation button fully depressed inside the tool with the cutter and spiral needle deployed.The account reported that the device deployed too far; the deployed needle was measured to be.608 in which is within tolerance specification.The actuation button was depressed approximately 1 inch inside the tool and split at the seam of the case.There were no signs of tampering to the device; therefore the root cause is undeterminable because the event occurred during the use of the device and the procedural operation is unavailable for our review.The device was returned with a broken case and a fully deployed needle, the reported complaint was not confirmed.The complaint is confirmed for the analyzed break.(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, the aortic punch device malfunctioned and came out too far.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5823440
• MDR Text Key: 51130726
• Report Number: 2242352-2016-00692
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2017
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25125830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1