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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 Material Rupture (1546); Calibration Problem (2890); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2019
Event Type  malfunction  
Event Description
Over the last two years, we have experienced numerous issues with teleflex's ac3 iabp fos catheters (arrow fiberoptix). Given all the incidents, our facility has removed fos catheters from use, and reverted to older transducer catheters. This report included a total of 21 events. A brief summary of the events is below; 6 events were related to frozen screen issues. 9 events were related to fiber optic sensor issues. 2 events were related to fiber optic sensor connector/calibration issues. 5 events were related to balloon rupture issues. Manufacturer response for arrow intra-aortic balloon catheter kit fiberoptix (iab), arrow intra-aortic balloon catheter kit fiberoptix (iab) (per site reporter).
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill boulevard
morrisville NC 27560
MDR Report Key9309473
MDR Text Key165980225
Report Number9309473
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 11/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN039792
Device Catalogue NumberIAB-05840-LWS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/05/2019
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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