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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 Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the package was opened, the doctor noted that the intra-aortic balloon (iab) was a bit bent. During insertion, the doctor noted that the spring wire guide could not pass through the central cavity of the balloon. As a result, the balloon was removed, and another attempt was made with a new balloon successfully. There was no report of delay in therapy. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). The reported compliant that the "iab kinked, guidewire could not pass" is confirmed. Two kinks were noted on the iab during the complaint investigation, and the guidewire could not successfully pass through the iab. The root cause of this complaint is undetermined. 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.
 
Event Description
It was reported that when the package was opened, the doctor noted that the intra-aortic balloon (iab) was a bit bent. During insertion, the doctor noted that the spring wire guide could not pass through the central cavity of the balloon. As a result, the balloon was removed, and another attempt was made with a new balloon successfully. There was no report of delay in therapy. There was no report of patient complication or serious injury and death.
 
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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 Key8248027
MDR Text Key133065200
Report Number3010532612-2018-00419
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberIAB-06840-U
Device Lot Number18F18B0060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No

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