MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL WIDE 8" CVD; APPLIER, SURGICAL, CLIP

Model Number IPN028180

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Laceration(s) (1946)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "while the pa was using the red clip appliers to clip artery branches on the endoscopic vein harvesting, the clip applier severed an artery." further information states that this event occurred during a coronary bypass surgery and the branches on the left internal mammary gland were being clipped on.The defect is reported as "the scissor like application had misaligned tips".The issue was resolved by repairing the mammary artery by suturing and using a new applier to complete the procedure.The procedure was completed successfully and estimated blood loss was "minimal".There was "no further harm, this prolonged the case for 15 minutes to assess the repair (lima).This did not extend or change the amount of blood loss for the patient, was able to use the mammary for conduit.Patient was discharged".

Manufacturer Narrative

Qn#(b)(4).The sample was not returned for investigation.The manufacturing site (tecomet) reports: "per customer provided information we are unable to perform a thorough dhr for the alleged defective instrument since lot information has not been provided.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All instruments of this type are 100% function tested and visually inspected prior to release to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed." other remarks: n/a corrected data: n/a.

Event Description

It was reported that "while the pa was using the red clip appliers to clip artery branches on the endoscopic vein harvesting, the clip applier severed an artery." further information states that this event occurred during a coronary bypass surgery and the branches on the left internal mammary gland were being clipped on.The defect is reported as "the scissor like application had misaligned tips".The issue was resolved by repairing the mammary artery by suturing and using a new applier to complete the procedure.The procedure was completed successfully and estimated blood loss was "minimal".There was "no further harm, this prolonged the case for 15 minutes to assess the repair (lima).This did not extend or change the amount of blood loss for the patient, was able to use the mammary for conduit.Patient was discharged".

• Brand Name: HZ APPLIER SMALL WIDE 8" CVD
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17297726
• MDR Text Key: 318763077
• Report Number: 3011137372-2023-00168
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 34026704622628
• UDI-Public: 34026704622628
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028180
• Device Catalogue Number: 137082
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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