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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION AORTIC PUNCH; AORTA PUNCH, SINGLE USE
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INTERNATIONAL BIOPHYSICS CORPORATION AORTIC PUNCH; AORTA PUNCH, SINGLE USE Back to Search Results
Model Number APL44
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/31/2021
Event Type  Injury  
Event Description
Patient was admitted for elective coronary artery bypass graft under ms an in ct2.When we were on the top end of the graft on the aorta, the aortic punch got stuck inside the aorta and did not release.This can cause serious damage to the aorta and dissect it.The surgeon needed to cut off around it to release the aortic punch.The surgery was complete successfully with no further complication.
 
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Brand Name
AORTIC PUNCH
Type of Device
AORTA PUNCH, SINGLE USE
Manufacturer (Section D)
INTERNATIONAL BIOPHYSICS CORPORATION
2101 e. st elmo road
suite 275
austin TX 78744
Manufacturer (Section G)
INTERNATIONAL BIOPHYSICS CORPORATION
2101 e. st elmo road
suite 275
austin TX 78744
Manufacturer Contact
geoffrey marcek
2101 e. st elmo road
suite 275
austin, TX 78744
5128140046
MDR Report Key12482944
MDR Text Key271865974
Report Number1645362-2021-00002
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 09/14/2021
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
Device Operator Health Professional
Device Expiration Date07/08/2024
Device Model NumberAPL44
Device Lot Number070820-9728
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/02/2021
Initial Date FDA Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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