MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC AORTIC CUTTERS, 5-PACK (4.3MM); CUTTER, SURGICAL

Model Number AORTIC CUTTERS, 5-PACK (4.3MM)

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (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.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during a coronary artery bypass procedure, aortic cutters, 5-pack (4.3mm) did not work when the operating button was pressed.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Patient effects.

• Brand Name: AORTIC CUTTERS, 5-PACK (4.3MM)
• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 9583069
• MDR Text Key: 188695127
• Report Number: 2242352-2020-00056
• Device Sequence Number: 1
• Product Code: FZT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: AORTIC CUTTERS, 5-PACK (4.3MM)
• Device Catalogue Number: AC-3043
• Device Lot Number: 25147248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2019
• 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