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

Model Number IPN914926

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event 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 patient had to receive surgical intervention upon readmittance.The first incident date is not known.

Manufacturer Narrative

Qn#(b)(4).Dhr 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.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

Event 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
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12371504
• MDR Text Key: 268281045
• Report Number: 3003898360-2021-00817
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704696315
• UDI-Public: 34026704696315
• Combination Product (y/n): N
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914926
• Device Catalogue Number: 002204
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention