MAUDE Adverse Event Report: TELEFLEX MEDICAL AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number MDP-40K

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Atrial Perforation (2511)

Event Date 09/03/2015

Event Type  Injury  

Event Description

During procedure, doctor used 4mm aortic punch which would not release, causing a tear in the arterial wall of the subclavian artery.Doctor was able to repair the wall but it was with difficulty.

• Brand Name: AORTIC PUNCH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 5480503
• MDR Text Key: 39685377
• Report Number: 5480503
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015,01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MDP-40K
• Device Lot Number: 74J1400869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 85