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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AORTIC PUNCH
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TELEFLEX MEDICAL AORTIC PUNCH Back to Search Results
Catalog Number MDP-40K
Device Problems Sticking (1597); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2018
Event Type  malfunction  
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 at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the current aortic punch used, the operation was not smooth, and after punching it got stuck and had difficulty disengaging.On punching the aorta, the device did not release there was difficulty in dispensing the punch.The device was removed, was not replaced, another attempt was made, treatment was not delayed, no complications or injury.
 
Manufacturer Narrative
(b)(4).The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No corrective actions can be implemented due the lack of product sample to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.
 
Event Description
It was reported that the current aortic punch used, the operation was not smooth, and after punching it got stuck and had difficulty disengaging.On punching the aorta, the device did not release there was difficulty in dispensing the punch.The device was removed, was not replaced, another attempt was made, treatment was not delayed, no complications or injury.
 
Manufacturer Narrative
(b)(4).Sample was received without its original package instead the sample was sent on a sterilized bag with a protective cap at the core.Note: at first sight, no signs of use were detected to the sample.Sample was reviewed with the format aortic punch codes quality inspection form (qa-pun-003/f1) on section: verify that core returns without obstructions- no problem found was detected to the sample when inspected.A portion of clean pork aorta was used in order to review the functionality of the sample.Five (5) cuts/punches were performed, no problem was found with the functionality of the aortic punch.Sample was analyzed in accordance to current specifications and manufacturing controls with no functional issues found.Based on the analysis of the sample received, customer complaint is not confirmed.However, manufacturing personnel was notified of this event for awareness.
 
Event Description
It was reported that the current aortic punch used, the operation was not smooth, and after punching it got stuck and had difficulty disengaging.On punching the aorta, the device did not release there was difficulty in dispensing the punch.The device was removed, was not replaced, another attempt was made, treatment was not delayed, no complications or injury.
 
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Brand Name
AORTIC PUNCH
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7373393
MDR Text Key103684509
Report Number3004365956-2018-00090
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/22/2022
Device Catalogue NumberMDP-40K
Device Lot Number74F1702105
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2018
Initial Date FDA Received03/27/2018
Supplement Dates Manufacturer Received05/11/2018
06/26/2018
Supplement Dates FDA Received05/15/2018
07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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