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

Model Number	IPN914925
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Incident occurred on (b)(6) 2022, involved an 80-year-old patient treated for bypass surgery coronary left internal mammary on posterolateral and right internal mammary on anterior interventricular under circulation extra bodily.During the intervention the clips self-removed from the internal breast on which they had been applied.Consequence: significant blood loss of 400 ml.Proximal tear bleeding of the right internal mammary artery required a vascular filling , norepinephrine and then continuous follow up.During postoperative follow up, we observed a postoperative bleeding that stopped after giving 2g of fibrinogen to the patient.Patient is fine, he was discharged on (b)(6) 2022 and left the hospital.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.Part number is not being manufactured currently, however, another part number from the same family was used 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-clip not reopened" was not observed in the current manufacturing process.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Incident occurred on (b)(6) 2022, involved an 80-year-old patient treated for bypass surgery coronary left internal mammary on posterolateral and right internal mammary on anterior interventricular under circulation extra bodily.During the intervention the clips self-removed from the internal breast on which they had been applied.Consequence: significant blood loss of 400 ml.Proximal tear bleeding of the right internal mammary artery required a vascular filling , norepinephrine and then continuous follow up.During postoperative follow up, we observed a postoperative bleeding that stopped after giving 2g of fibrinogen to the patient.Patient is fine, he was discharged on (b)(6) 2022 and left the hospital.

• 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: 15243121
• Report Number: 3003898360-2022-00414
• Device Sequence Number: 11954168
• Product Code: FZP
• UDI-Device Identifier: 24026704696363
• UDI-Public: 24026704696363
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/16/2022

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 Model Number: IPN914925
• Device Catalogue Number: 002200
• Device Lot Number: 73B2200445
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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; Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male