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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HP APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HP APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP Back to Search Results
Model Number IPN008881
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Bleeding (1888)
Event Date 10/23/2021
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event 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.
 
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 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.
 
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Brand Name
HP APPLIER MED 8" CVD
Type of Device
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 Key12829616
MDR Text Key280894691
Report Number3011137372-2021-00316
Device Sequence Number1
Product Code GDO
UDI-Device Identifier24026704696448
UDI-Public24026704696448
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN008881
Device Catalogue Number533110
Device Lot Number06K1642042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Life Threatening;
Patient Age73 YR
Patient SexMale
Patient Weight63 KG
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