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

Model Number	RCL40
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Testing of the aortic punch received from the customer did not show any manufacturing defects or malfunction.When tested, the device engaged and disengaged without any jamming and functioned as intended.The root cause of the reported complaint condition is unknown.Quest will continue to monitor complaint trends.
Event or Problem Description
It was reported to quest medical by (b)(6) health that, during the use of an rcl40 aortic punch, the punch got stuck, causing a tear to the aorta.The surgeon had to repair the hole with a pericardial patch.

• Brand Name: CLEANCUT 4.0MM ROTATING AORTIC PUNCH
• Common Device Name: 4.0MM ROTATING AORTIC PUNCH
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• MDR Report Key: 11962830
• Report Number: 1649914-2021-00005
• Device Sequence Number: 14299999
• Product Code: DWS
• UDI-Device Identifier: 10634624374000
• UDI-Public: 10634624374000
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: RCL40
• Device Catalogue Number: RCL-40
• Device Lot Number: 0617891F01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85