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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 IPN915325
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/15/2024
Type of Reportable Event Malfunction
Event or Problem Description
After termination from cpb (cardiopulmonary bypass), a 40cc iabp catheter was placed under tee (transesophageal echocardiography) guidance.The balloon was initiated; however, fill support was not achieved and the balloon could be visualized not full inflating.This is a known issue with the fda, though affected lot numbers have not been recalled.The 40cc catheter was removed and another catheter was placed to provide support.
 
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Brand Name
ARROW
Common Device Name
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd.
morrisville NC 27560
MDR Report Key20864183
Report Number20864183
Device Sequence Number8831430
Product Code DSP
UDI-Device Identifier10801902161977
UDI-Public(01)10801902161977
Combination Product (Y/N)N
Initial Reporter StateTN
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 11/27/2024
Report Date (Section F) 11/27/2024
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
Operator of Device Health Professional
Device Model NumberIPN915325
Device Catalogue NumberIAB-S840C
Device Lot Number18F24F0133
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer12/06/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/06/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient Age61 YR
Patient SexMale
Patient Weight79 KG
Date Report Sent to FDA11/27/2024
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