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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon was found kinked just below the balloon. Therefore a new iab was used. There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon was found kinked just below the balloon. Therefore a new iab was used. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported compliant of iab kinked is confirmed. A kink to the central lumen was noted during the visual inspection of the returned iab, and a guidewire could not pass successfully through the central lumen during functional testing. The root cause of the kink is undetermined but the potential cause is due to customer handling. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8398858
MDR Text Key138090936
Report Number3010532612-2019-00041
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberIAB-06840-U
Device Lot Number18F18K0024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No

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