MAUDE Adverse Event Report: MAQUET CV AORTIC CUTTER 4.3MM; CLAMP, VASCULAR

Catalog Number C-AC-3043

Device Problems Failure to Fire (2610); Fail-Safe Problem (2936)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a coronary artery bypass procedure, aortic cutter 4.3mm didn't actuate when pushing the button after releasing the safety lock button.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure, aortic cutter 4.3mm didn't actuate when pushing the button after releasing the safety lock button.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Evidence of blood and signs of clinical use was observed.The safety lock on the cutter was disengaged and the actuation button was fully depressed.There were no signs of tampering to the device.There were no defects in regard to the needle.The actuation button was depressed approximately 1 inch inside the tool.No visual defects were detected.Based on the return condition of the device and the evaluation results, the reported failure "failure to fire; cutter; failed to actuate" is not confirmed.

• Brand Name: AORTIC CUTTER 4.3MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8357543
• MDR Text Key: 137037392
• Report Number: 2242352-2019-00203
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2019
• Device Catalogue Number: C-AC-3043
• Device Lot Number: 25137344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1