MAUDE Adverse Event Report: QUEST MEDICAL, INC CLEANCUT AORTIC PUNCH

Model Number RCL40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

This report was received from an ous customer and the alleged incident happened ous.The medwatch is being submitted because a similar device is sold in the us.The complaint sample was not returned for evaluation and a dhr review could not be completed because the lot number was not provided by the customer.The customer indicated that the incident may have resulted from the surgeon not hearing tactile sounds, which he is used to hearing from similar devices marketed by other companies, indicating a cut has been made.The root cause of the alleged event is unknown.Quest medical has made several attempts to get more information from the customer and no response has been received.A follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered during use of the aortic punch.The report states that while being trialled by the surgeon, the aortic punch ripped the aorta.There were no reported patient complications as a result of the alleged issue.

• Brand Name: CLEANCUT AORTIC PUNCH
• Type of Device: AORTIC PUNCH
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7375831
• MDR Text Key: 103944694
• Report Number: 1649914-2018-00033
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

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?: Yes
• Device Operator: No Information
• Device Model Number: RCL40
• Device Catalogue Number: RCL40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1