MAUDE Adverse Event Report: TELEFLEX MEDICAL; AORTIC PUNCH

Catalog Number MDP-60K

Device Problems Break (1069); Material Disintegration (1177); Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Tissue Damage (2104)

Event Date 03/06/2018

Event Type  Injury  

Event Description

When doctor used the 6.0 mm punch on the external iliac artery he said it "disintegrated" and stuck to the tissue.He had difficulty removing it.The punch caused damage to the tissue and the external iliac artery.It necessitated us "going back into slush".The damage to the tissue required us to call the vascular team to come in and repair the artery with a graft.The device and packaging were saved and brought to clinical engineering for evaluation.An exemplar from the same lot was also obtained.It seems a piece of tissue was jammed between the cutting ring and the center plunger and the plastic ring on the end of the instrument broke off when the action was reversed, making it impossible to clear the jammed tissue.Exemplar device from same lot was tested with a piece of rubber glove.While it punched a hole in the glove, the punched out section jammed in the cutter.When trying to free the jam, the plastic ring popped off and flew across the room and was lost.So there are two issues; the cutter tends to jam and the plastic ring on the distal end of the device is easy to break off when trying to clear a jam.

• Type of Device: AORTIC PUNCH
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 7356708
• MDR Text Key: 102999419
• Report Number: 7356708
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: MDP-60K
• Device Lot Number: 74H1702723
• Other Device ID Number: *+H196MDP60K1W*
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR