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

Model Number IPN004607

Device Problem Failure to Align (2522)

Patient Problems Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Cabg procedure.Using the new ligaclips and applicators.At the end of the procedure and during a period of hypertension (140mmhg systolic) three of the ligaclips on vein branches became dislodged and the branches required suturing.At the beginning of the case when checking the vein, likewise, 2 of the clips had cut through requiring revision with sutures.Checked with scrub nurse and definitely the correct applicators were being used for the new clips the older clips have different applicators.Very unusual in my experience to see this on multiple clips raising the possibility of device failure.Speaking to colleagues it appears that they have also had incidents of clip failure with the new clips both migrating and cutting through.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4)-piece lot in january of 2018.This instrument has additional lot coding on the shank of the handle of r-06-21 signifying that it has been sent for repair previous to this complaint.Further evaluation shows that the tips of the jaws are slightly misaligned with each other in the closed position.We are able to validate this complaint.We are unable to determine what caused the tips of the jaws to become slightly misaligned in the closed position but mishandling of this device at the end user's facility is suspected.All (b)(4) 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

Cabg procedure.Using the new ligaclips and applicators.At the end of the procedure and during a period of hypertension (140mmhg systolic) three of the ligaclips on vein branches became dislodged and the branches required suturing.At the beginning of the case when checking the vein, likewise, 2 of the clips had cut through requiring revision with sutures.Checked with scrub nurse and definitely the correct applicators were being used for the new clips the older clips have different applicators.Very unusual in my experience to see this on multiple clips raising the possibility of device failure.Speaking to colleagues it appears that they have also had incidents of clip failure with the new clips both migrating and cutting through.The patient's condition was reported as fine.

• 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: 12934939
• MDR Text Key: 281755527
• Report Number: 3011137372-2021-00332
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004607
• Device Catalogue Number: 237081
• Device Lot Number: 06B1746641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention