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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 Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the doctor was performing the procedure according to the instruction for use (ifu). After, passing the guide wire the doctor attempted to pass the intra-aortic balloon (iab) catheter through, but could not. As a result, the doctor replaced the catheter with a new set and another attempt was made successfully. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
Qn#(b)(4). Teleflex received the device for investigation. The reported complaint of iab tight over guidewire is not confirmed. The returned device passed visual and functional test specifications. The root cause of the complaint is undetermined. The lot number (18f17e0051) reported on the complaint report does not match the lot number on the returned sample. The lot number of the returned sample is 18f15a0030. The iab device sent to teleflex was expired. The device expiration date was (b)(6) 2017. The reported event took place in (b)(6) 2018. No further action required at this time.
 
Event Description
It was reported the doctor was performing the procedure according to the instruction for use (ifu). After, passing the guide wire the doctor attempted to pass the intra-aortic balloon (iab) catheter through, but could not. As a result, the doctor replaced the catheter with a new set and another attempt was made successfully. There was no report of patient complication or serious injury and death.
 
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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 Key7752177
MDR Text Key116082255
Report Number3010532612-2018-00241
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 07/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Catalogue NumberIAB-S840C
Device Lot Number18F15A0030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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