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

Model Number IPN004607

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.

Event Description

Received call from senior staff nurse to be advised that during a coronary artery bypass graft they had a number of clips failures (10+), she was not in case so is unaware of how it was resolved.She believes patient condition is okay.This is an account that is trialing the horizon clips as a hemoclip replacement for when it is discontinued this year.Issue: clip failure during use on both the mammary (prof) and vein harvest (adnan).The nurse is going to confirm the lot number of the clips used and is requesting for the appliers to be decontaminated and quarantined.I have arranged to go in on wednesday to inspect the appliers and gather further details from surgical team.I am advised photos were taken and clinical lead go was called in to observe the issue.The appliers were new appliers, they have been used only during the past 3 weeks.I will be able to identify how many times they have been processed after wednesday.The customer used all four appliers during the case, if an applier was at fault, which caused the clips to not close properly then it could be any one of the four appliers from the set.I have checked the appliers myself and cannot see an obvious defect.I am not able to say if there was a problem with the clip, or a problem with the applier which caused a clip issue, or indeed neither option and user error.I can however say the customer is an experienced user of our clips, as was the rest of the team that was involved with the case.Clinical consequences: medical intervention was necessary due to the alleged issue.

Manufacturer Narrative

Qn# (b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This device was produced at the tecomet, inc.Kenosha wi facility as part of a 100-piece lot in august of 2020.Evaluation of the returned instrument shows that the tips are aligned in the open and closed position and that this instrument is able to pick-up, retain, closed and release multiple clips both with and without the use of silastic test tubing.Evaluation of 5 closed clips shows that maximum eye gap specification of.0073 measured at (.0013-.0027) and the maximum leg gap specification of.0060 measured at (.0026-.0032) verifying that this instrument performs as designed.We were unable to find any non-conforming features on this device therefore we are unable to validate this complaint.We are unable to determine what caused the alleged defect at the end user's facility.All 100 instruments from this lot were 100% visually inspected and function tested prior to shipment 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.

Event Description

Received call from senior staff nurse to be advised that during a coronary artery bypass graft they had a number of clips failures (10+), she was not in case so is unaware of how it was resolved.She believes patient condition is okay.This is an account that is trialing the horizon clips as a hemoclip replacement for when it is discontinued this year.Issue: clip failure during use on both the mammary (prof) and vein harvest (adnan).The nurse is going to confirm the lot number of the clips used and is requesting for the appliers to be decontaminated and quarantined.I have arranged to go in on wednesday to inspect the appliers and gather further details from surgical team.I am advised photos were taken and clinical lead go was called in to observe the issue.The appliers were new appliers, they have been used only during the past 3 weeks.I will be able to identify how many times they have been processed after wednesday.The customer used all four appliers during the case, if an applier was at fault, which caused the clips to not close properly then it could be any one of the four appliers from the set.I have checked the appliers myself and cannot see an obvious defect.I am not able to say if there was a problem with the clip, or a problem with the applier which caused a clip issue, or indeed neither option and user error.I can however say the customer is an experienced user of our clips, as was the rest of the team that was involved with the case.Clinical consequences: medical intervention was necessary due to the alleged issue.

• Brand Name: HZ APPLIER MED 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13916443
• MDR Text Key: 289522758
• Report Number: 3011137372-2022-00044
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004607
• Device Catalogue Number: 237081
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1