MAUDE Adverse Event Report: QUEST MEDICAL, INC. PERFECTCUT ROTATING AORTIC PUNCH 4.0 MM; CARDIOVASCULAR SURGICAL INSTRUMENT

Model Number RCB40

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2016

Event Type  malfunction  

Event Description

The international distributor ((b)(4)) reported an issue they encountered with an aortic punch.Their report stated that during incoming inspection at their facility of the product they observed one package that appeared open.The device has not been returned to the manufacturer for evaluation.

Manufacturer Narrative

The device package (pouch) was returned for evaluation.It was open at one edge where it appeared to have been partially peeled open.Visual examination of the device packaging found evidence on the tyvek and mylar portion of the package that the appropriate seal from the manufacturing process had been in place.The alleged complaint condition could not be confirmed.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: PERFECTCUT ROTATING AORTIC PUNCH 4.0 MM
• Type of Device: CARDIOVASCULAR SURGICAL INSTRUMENT
• 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: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 6185995
• MDR Text Key: 63108271
• Report Number: 1649914-2016-00069
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

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: Other
• Device Expiration Date: 09/21/2019
• Device Model Number: RCB40
• Device Lot Number: 0520676S09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention