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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S730C
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab) it was found that the guidewire was stuck in the iab. As a result, the iab was removed. There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab) it was found that the guidewire was stuck in the iab. As a result, the iab was removed. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iab tight over guidewire is confirmed. Upon investigation, the iab was noted with a part of a guidewire that remained stuck within the central lumen, creating a blockage. Additionally, the central lumen was noted kinked, which may have caused guidewire insertion difficulty. The root cause of the damage to the central lumen is undetermined but a potential cause is 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. Additionally, damage to the "arrow" packaging sticker that retains the iab bladder in the packaging tray was noted during the investigation. This damage indicates the iab was not prepped correctly per the instructions for use (ifu). An in-service has been requested to reiterate the ifu to the customer. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends.
 
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Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8778191
MDR Text Key150696985
Report Number3010532612-2019-00212
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberIAB-S730C
Device Lot Number18F18A0034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No

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