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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN039792
Device Problems Deflation Problem (1149); Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 10/31/2020
Event Type  malfunction  
Event Description
Elderly male with no prior history of cardiac disease developed chest heaviness, shortness of breath (sob), nausea, and sweating.Ekg consistent with acute anterior inferior wall st-segment elevation myocardial infarction (stemi).Cath lab team took patient emergently to cath lab.Patient had stent placed in right coronary artery (rca) and aortic balloon pump was placed.The next day, helium loss alarm triggered concern with intra-aortic balloon rupture.Intra-aortic balloon pump (iabp) removed.
 
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Brand Name
ARROW
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key10893949
MDR Text Key217977382
Report Number10893949
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/02/2020
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 No Information
Device Model NumberIPN039792
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20C0034
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2020
Event Location Hospital
Date Report to Manufacturer11/24/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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