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

Model Number RCL50BNS

Device Problems Material Too Rigid or Stiff (1544); Material Deformation (2976); No Apparent Adverse Event (3189)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This device is manufactured by quest medical and sold non-sterile to other manufacturers/distributors who carry out further processing before it is sold to the end user.It is unknown what complications may have resulted from the alleged incident.No information was provided on the patient involved in the surgery or on the extent of any complications that may have arisen from the alleged issue.As of the date of this report, two requests have been sent to the customer requesting for additional details on patient information and resulting patient complications, if any.No response has been received.The device was discarded by the end user.A similar device from the same lot will be evaluated if available and a dhr review will be performed.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 the edges of the aortic punch are rough and resulted in a tear in the patient's delicate cardiac tissue.

Manufacturer Narrative

In a subsequent email sent by the customer after the initial mdr report was filed, the customer stated that there were no patient complications resulting from the alleged issue complained about.The customer also stated that the surgeon had general quality concerns about the product.Specific details on the surgeon's concerns were not provided.As part of internal investigations into this complaint, a dhr review was conducted and no anomalies were identified.A 24 month complaint history review was also conducted and no similar complaint was identified.The complaint sample was not returned by the customer.The customer sent samples from the same lot complained about and the samples were visually inspected for rough edges as specified in the initial complaint and no anomaly was identified.The samples were functionally inspected for cur force and were found to be within specifications.The root cause of the alleged issue is not manufacturing related.

• 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: 7173838
• MDR Text Key: 96837692
• Report Number: 1649914-2018-00006
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

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
• Device Operator: No Information
• Device Model Number: RCL50BNS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other