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

Model Number	IPN028165
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history review for the product horizon ti small red 25 pouches with 24 lot# 73f2100291 was manufactured on 06/08/2021 a total of (b)(4) pieces.Lot was released on 06/23/2021.Dhr investigation did not show issues related to complaint.
Event or Problem Description
Surgeon states clips not closing on vessel, causing vessel leak.Additional information: the clips were found to be not closing during a procedure, tram flap for bilateral mastectomy.The surgeon did not permit bleeding to continue; could have been significant but was immediately identified and controlled.No additional procedure was needed to resolve the issue.The surgeon used diathermy to control the bleeding.The issue occurred with several appliers.These were then used to successfully apply other clips.All appliers used in the case were only replaced two weeks prior and were in perfect working order.
Additional Manufacturer Narrative
(b)(4).The device history review for the product horizon ti small red 25 pouches with 24 lot#: 73f2100291 was manufactured on 06/08/2021 a total of (b)(4) pieces.Lot was released on 06/23/2021.Dhr investigation did not show issues related to complaint.The customer returned one unopened representative sample of 001205 horizon ti small red 25 pouches with 24 for investigation.The actual sample was not returned.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the clips appear typical.No defects or anomalies were observed.Functional inspection was performed on the returned representative samples.A lab inventory clip applier was used.All clips from each 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 samples (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 samples that were returned.The actual sample was not returned.
Event or Problem Description
Surgeon states clips not closing on vessel, causing vessel leak.Additional information: the clips were found to be not closing during a procedure, tram flap for bilateral mastectomy.The surgeon did not permit bleeding to continue; could have been significant but was immediately identified and controlled.No additional procedure was needed to resolve the issue.The surgeon used diathermy to control the bleeding.The issue occurred with several appliers.These were then used to successfully apply other clips.All appliers used in the case were only replaced two weeks prior and were in perfect working order.

• Brand Name: HORIZON TI SMALL RED 25 POUCHES WITH 24
• 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: 14282013
• Report Number: 3003898360-2022-00150
• Device Sequence Number: 6743290
• Product Code: FZP
• UDI-Device Identifier: 34026704624776
• UDI-Public: 34026704624776
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 04/13/2022

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 Expiration Date: 06/07/2026
• Device Model Number: IPN028165
• Device Catalogue Number: 001205
• Device Lot Number: 73F2100291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown