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

Model Number	IPN028165
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is the third time the same plastic surgeon at (b)(6) hospital has had an issue with 001205 clips lacerating the blood vessels they are supposed to be ligating.The surgeon then has to use diathermy to seal the vessels as the laceration causes bleeding.The clips are used in tram flap reconstructions on post mastectomy patients and are used to ligate abdominal vessels while lifting the flap.
Additional Manufacturer Narrative
(b)(4).The device history review for the product horizon ti small red 25 pouches with 24 lot# 73g1900177 investigation did not show issues related to complaint.
Additional Manufacturer Narrative
(b)(4).Per dhr the product horizon ti small red 25 pouches with 24 lot# 73g1900177 was manufactured on 07/03/2019 a total of (b)(4) pieces.Lot was released on 07/18/2019.Dhr investigation did not show issues related to complaint.Visual, dimensional, and functional inspection could not be performed because the sample was lost.P/n 001205 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 59 samples were taken from the current production, the samples were functionally inspected, and during the test issue reported "ligation failure-other" was not observed in the current manufacturing process.A conclusion cannot be reached as the sample was lost.
Event or Problem Description
This is the third time the same plastic surgeon at ascot hospital has had an issue with 001205 clips lacerating the blood vessels they are supposed to be ligating.The surgeon then has to use diathermy to seal the vessels as the laceration causes bleeding.The clips are used in tram flap reconstructions on post mastectomy patients and are used to ligate abdominal vessels while lifting the flap.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 14684709
• Report Number: 3003898360-2022-00243
• Device Sequence Number: 5083940
• 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): 05/31/2022

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: 07/02/2024
• Device Model Number: IPN028165
• Device Catalogue Number: 001205
• Device Lot Number: 73G1900177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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: Required Intervention
• Patient Sex: Unknown