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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S840C
Device Problems Complete Blockage (1094); No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that after the intra-aortic balloon (iab) catheter was implanted, no pressure waveform was found. The pressure transducer was replaced, but no improvements. As a result, a new catheter was used, and the pressure waveform was restored to normal. There was no report of patient complication or serious injury and death.
 
Event Description
It was reported that after the intra-aortic balloon (iab) catheter was implanted, no pressure waveform was found. The pressure transducer was replaced, but no improvements. As a result, a new catheter was used, and the pressure waveform was restored to normal. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for the reported complaint. The reported complaint of iab central lumen occluded is confirmed. The aspi ration/flushing test was successful; however, a kink was noted to the central lumen and is the potential cause of the reported complaint. The root cause of the kinked central lumen 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. This will be monitored for any developing trends. No further action required at this time.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8060025
MDR Text Key126962813
Report Number3010532612-2018-00335
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 10/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17K0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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