MAUDE Adverse Event Report: TELEFLEX MEDICAL HP APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP

Model Number	IPN008881
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
7 ligaclips falling off the saphenous vein, 2 from side branch on a grafted coronary artery, 5 from the lighted end of the saphenous vein in the donau leg.Ligation clip applicator identified and tested and removed from circulation after concerns identified.Clinical incident raised and serious investigation process commenced at hospital.Clinical consequences: pea cardiac arrest with emergency resternotomy on itu and arrest of bleeding from bleeding side branch of saphenous vein graft to coronary artery.Hematoma of donor leg site.
Additional Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50-piece lot in october of 2017.Evaluation of the returned instrument shows that the tips are slightly misaligned in the closed position.Although the tips are slightly misaligned in the closed position functional testing shows that this instrument is able to pick-up , retain, close and release multiple clips.8 closed clips where measured as they were at time of production and all 8 clips measured to hemoclip plus applier specifications of.0078" max.Leg gap at (.0041"-.0049") and.0061" max.Eye gap at (.0019"-.0035") we are unable to determine what caused the tips to be slightly misaligned but mishandling at the end user's facility is suspected.We are also unable to determine what caused the alleged defect at the end user's facility since all the leg and eye gaps of the clips closed during our testing measured within factory specifications.
Event or Problem Description
7 ligaclips falling off the saphenous vein, 2 from side branch on a grafted coronary artery, 5 from the lighted end of the saphenous vein in the donau leg.Ligation clip applicator identified and tested and removed from circulation after concerns identified.Clinical incident raised and serious investigation process commenced at hospital.Clinical consequences: pea cardiac arrest with emergency resternotomy on itu and arrest of bleeding from bleeding side branch of saphenous vein graft to coronary artery.Haematoma of donor leg site.

• Brand Name: HP APPLIER MED 8" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12829616
• Report Number: 3011137372-2021-00316
• Device Sequence Number: 4364836
• Product Code: GDO
• UDI-Device Identifier: 24026704696448
• UDI-Public: 24026704696448
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/09/2021

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: IPN008881
• Device Catalogue Number: 533110
• Device Lot Number: 06K1642042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG