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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL UNKNOWN AORTIC PUNCH 4.0
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TELEFLEX MEDICAL UNKNOWN AORTIC PUNCH 4.0 Back to Search Results
Catalog Number SURGICAL UNKNOWN
Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Medwatch report number: mw5074959.The device history review could not be conducted since the lot number provided belongs to other family of product.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that a 4.0 disposable aortic punch was placed in the artery.The punch jammed and would not open.Removal resulted in a hole in the artery.The hole was repaired.The patient's condition is unknown at this time.
 
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Brand Name
UNKNOWN AORTIC PUNCH 4.0
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key7353057
MDR Text Key102898415
Report Number3004365956-2018-00078
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 02/22/2018
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
Device Operator Health Professional
Device Catalogue NumberSURGICAL UNKNOWN
Device Lot Number74G1701229
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/22/2018
Initial Date FDA Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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