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

Model Number IPN914925

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 279574654
• Report Number: 3003898360-2021-01015
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704696363
• UDI-Public: 24026704696363
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other