MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 25 POUCHES WITH 24 CLIPS; CLIP, IMPLANTABLE

Model Number	IPN914926
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#: (b)(4).A visual, dimensional, or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.The customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Multiple incidence of one doctors patients returning after cv procedures.Horizon clips have slipped off post-op.Follow-up report indicates that 4 patients were affected over the past year with horizon clip occlusion issues.All patients were subsequently ligated with automatic metal clip applier.One (1) patient had to receive surgical intervention upon readmittance.The first incident date is not known.

• Brand Name: HORIZON TI MED 25 POUCHES WITH 24 CLIPS
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12371228
• Report Number: 3003898360-2021-00754
• Device Sequence Number: 1206535
• Product Code: FZP
• UDI-Device Identifier: 34026704696315
• UDI-Public: 34026704696315
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

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: IPN914926
• Device Catalogue Number: 002204
• Device Lot Number: 0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention