MAUDE Adverse Event Report: QUEST MEDICAL INC. PERFECTCUT ROTATING AORTIC PUNCH 4.0MM

Model Number	RCB40
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical has not yet completed its investigation of this device.A supplemental report will be filed at the conclusion of this investigation.Quest will continue to monitor complaint trends for this complaint condition.
Event or Problem Description
It was reported to quest medical.Inc.That the device allegedly malfunctioned and unintentionally tore the subclavian artery during the procedure.A similar device from the same lot was opened and used to complete the procedure successfully.
Additional Manufacturer Narrative
An analysis of the sample was returned and evaluated; biological tissue was found obstructing the mechanism, preventing full actuation.It could not be determined whether the tissue caused the failure or was a result of it.No visible mechanical or assembly-related defects were observed.Device history record review showed all manufacturing and inspection steps were completed without deviation.Functional testing at release was passed.No similar issues were noted in-process.Quest medical will continue to monitor complaints for trends.

• Brand Name: PERFECTCUT ROTATING AORTIC PUNCH 4.0MM
• Common Device Name: AORTIC PUNCH
• Manufacturer (Section D): QUEST MEDICAL INC.; 1 allentown parkway; allen TX 75002 4211
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002 4211
• Manufacturer Contact: jan hodges ; 1 allentown parkway; allen, TX 75002-4211 ; 9723909800
• MDR Report Key: 21185542
• Report Number: 1649914-2024-00006
• Device Sequence Number: 8285061
• Product Code: DWS
• UDI-Device Identifier: 10634624324005
• UDI-Public: 10634624324005
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RCB40
• Device Lot Number: 72557
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown