MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 6/CART 180/BOX; CLIP, IMPLANTABLE

Model Number	IPN914925
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clips were springing off vessels and failing to clamp.Clips were tested off the patient and appeared to work normally.Issue only occurred when ligating vessel using multiple different appliers.Issue occurred with multiple surgeons and scrub nurses, and only when the lot number changed did the clips work normally.Clips were inspected next day by tfx territory manager and tested with 1 of their appliers, suspect that appliers may need to be replaced as clips were partially compressed after loading.
Additional Manufacturer Narrative
(b)(4).The device history review for the product horizon ti med 6/cart 180/box lot# 73j2100021 investigation did not show issues related to the complaint.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unopened representative sample of 002200 horizon ti med 6/cart 180/box for investigation.The actual sample was not returned.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the clips appear typical.No defects or anomalies were observed.Functional inspection was performed on the returned representative sample.A lab inventory clip applier was used.All clips from the representative sample were able to properly load into the applier.The clips were able to close properly when applied to over-stressed surgical tubing.No functional issues were found with the returned clips.However, no root cause could be determined since the actual sample (the clips that failed) were not returned.The ifu for this product, l02428, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as there were no functional issues found with the representative sample that was re turned.The actual sample was not returned.The reported complaint of "ligation failure-clip not closing" could not be confirmed based on the returned product.One representative sample was returned.Upon functional inspection, no problems were found as clips could be loaded into the jaws of a lab inventory applier and close when applied to over-stressed surgical tubing.No functional issues were found with the returned clips.However, no root cause could be determined since the actual samples (the clips that failed) were not returned.
Event or Problem Description
Clips were springing off vessels and failing to clamp.Clips were tested off the patient and appeared to work normally.Issue only occurred when ligating vessel using multiple different appliers.Issue occurred with multiple surgeons and scrub nurses, and only when the lot number changed did the clips work normally.Clips were inspected next day by tfx territory manager and tested with 1 of their appliers, suspect that appliers may need to be replaced as clips were partially compressed after loading.

• Brand Name: HORIZON TI MED 6/CART 180/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14618531
• Report Number: 3003898360-2022-00239
• Device Sequence Number: 17286733
• Product Code: FZP
• UDI-Device Identifier: 24026704696363
• UDI-Public: 24026704696363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132658
• 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): 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2026
• Device Model Number: IPN914925
• Device Catalogue Number: 002200
• Device Lot Number: 73J2100021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown