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

Model Number	IPN914925
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
A clip came off during a procedure leading the surgeon to suture the vessel.The other reported incident is that the clip did not occlude the vessel but tip and hinge were meeting.The clinical lead does not have the specific details of the incidents and has given me the email of a surgeon who deals with governance to request from him.As soon as i have further details i will provide.Additional information: the procedure was a cabg.The saphenous vein was prepared.It was described as the clips cut through the vessel when applied so vein was leaking in 3 to 4 areas.When they took the patient off bypass they had a lot of blood around the right hand side of rhe heart where the clip had cut through the branch of vein.Surgeon over suture the vessels to ensure proper closure.No issues post surgery reported with patient.He felt he had a similar incident around a month ago.
Event or Problem Description
A clip came off during a procedure leading the surgeon to suture the vessel.The other reported incident is that the clip did not occlude the vessel but tip and hinge were meeting.The clinical lead does not have the specific details of the incidents and has given me the email of a surgeon who deals with governance to request from him.As soon as i have further details i will provide.Additional information: the procedure was a cabg.The saphenous vein was prepared.It was described as the clips cut through the vessel when applied so vein was leaking in 3 to 4 areas.When they took the patient off bypass they had a lot of blood around the right hand side of rhe heart where the clip had cut through the branch of vein.Surgeon over suture the vessels to ensure proper closure.No issues post surgery reported with patient.He felt he had a similar incident around a month ago.
Additional Manufacturer Narrative
(b)(4).Dhr review could not be conducted since the lot number was not provided.Revision of d000761 rev 05 was performed and the failure mode is already including it, no update is required.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.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12737639
• Report Number: 3003898360-2021-01015
• Device Sequence Number: 4099146
• Product Code: FZP
• UDI-Device Identifier: 24026704696363
• UDI-Public: 24026704696363
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/18/2021

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: IPN914925
• Device Catalogue Number: 002200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Other
• Patient Sex: Unknown