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

Model Number	IPN004607
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011137372-2021-00332
• Device Sequence Number: 14691967
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown