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

Model Number RCB40

Device Problems Sticking (1597); Failure to Cut (2587); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Device 3 of 3.Refer to 1649914-2014-00033 and 1649914-2014-00032.The foreign hosp (b)(6)reported device malfunctions involving the aortic punch during three procedures.The clinician reported that in each instance the punch failed to make the cut as desired, but instead when activated the release mechanism became stuck in the aortic wall.Another punch (different mfr) was used to successfully complete each of the procedures.There were no patient complications reported as a result of the alleged malfunctions.It is anticipated that the devices (3 in total) will be returned to the mfr for eval.

Manufacturer Narrative

(b)(4).Device 3 of 3.Quest med inc has limited info related to the patient's med history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical inc defers to the patient's physician regarding medical history.

• Brand Name: PERFECTCUT ROTATING AORTIC PUNCH
• Manufacturer (Section D): QUEST MEDICAL, INC.; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown pkwy.; allen, TX 75002 ; 9723326338
• MDR Report Key: 4080505
• MDR Text Key: 20659221
• Report Number: 1649914-2014-00034
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/27/2014

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: Health Professional
• Device Expiration Date: 07/08/2016
• Device Model Number: RCB40
• Device Lot Number: 0447163U02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention