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

Catalog Number	002200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.
Event or Problem Description
It was reported that "the surgeon found that could not be driven in." to continue the procedure, the medical professional changed to a new set.The patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one cartridge of 002200 horizon ti med 6/cart 180/box for investigation.The clip cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that there were two clips remaining in the cartridge.Evidence of use in the form biological material was observed on the cartridge.No defects or anomalies were observed.Functional inspection was performed on the returned sample.A lab inventory clip applier was used.All remaining clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.No functional issues were found with the returned clips.The ifu for this product 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 device history record review was performed, and no relevant findings were identified.The reported complaint of "ligation failure-clip not closing" was not confirmed based upon the sample received.Upon functional inspection, all remaining clips were able to properly load into the jaws of a lab inventory applier and were successfully applied to over-stressed surgical tubing.No damages were observed to any of the returned clips.Since no functional issues were found with the returned clips, the reported issue could not be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that " the surgeon found that could not be driven in".To continue the procedure, the medical professional changed to a new set.The patient's current condition is reported as "fine".

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20303828
• Report Number: 3003898360-2024-01278
• Device Sequence Number: 12982586
• Product Code: FZP
• UDI-Device Identifier: 04026704410248
• UDI-Public: (01)04026704410248(11)230907(17)280905(10)73J2300209(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 002200
• Device Lot Number: 73J2300209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown