MAUDE Adverse Event Report: TELEFLEX MEDICAL DIAMOND-EDGE DISPOSABLE AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number DP-52K

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the arterial punch was applied twice.It would not release the second time.Then the handle came off.There was small damage to the artery but not critical according to the surgeon.

Manufacturer Narrative

(b)(4).A dhr review could not be conducted since the lot number was not provided.A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.No conclusion can be established at this time based on the lack of defective of sample.It is necessary the physical sample in order to perform a properly investigation.If the product sample becomes available this complaint will be reopened.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

It was reported that the arterial punch was applied twice.It would not release the second time.Then the handle came off.There was small damage to the artery but not critical according to the surgeon.

• Brand Name: DIAMOND-EDGE DISPOSABLE AORTIC PUNCH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8124330
• MDR Text Key: 129041731
• Report Number: 3004365956-2018-00358
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

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: Health Professional
• Device Catalogue Number: DP-52K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1