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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 6/CART 180/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HORIZON TI MED 6/CART 180/BOX; CLIP, IMPLANTABLE Back to Search Results
Model Number IPN028171
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/18/2021
Type of Reportable Event Malfunction
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
The procedure was a cabg.He had a case where a couple of clips came off the saphenous vein when pressure delivered to the harvested vein.He said this can happen and he was not overly concerned at this stage as it only happened the once.
 
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Brand Name
HORIZON TI MED 6/CART 180/BOX
Common Device Name
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12737694
Report Number3003898360-2021-01013
Device Sequence Number14477939
Product Code FZP
UDI-Device Identifier24026704696363
UDI-Public24026704696363
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K132658
Number of Events Summarized1
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
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 NumberIPN028171
Device Catalogue Number002200
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/18/2021
Initial Report FDA Received Date11/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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