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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 Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).For related complaint and event see mdr #3010532612-2018-00368.And tc # (b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab) it was noted by the staff that the new balloon was defective and was difficult to pass through the wire.As a result, a new iab kit was opened and used on the patient.There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4) for related complaint and event see mdr #3010532612-2018-00368 and (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab tight over guidewire is not able to be confirmed.The root cause of the 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.This will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required at this time.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab) it was noted by the staff that the new balloon was defective and was difficult to pass through the wire.As a result, a new iab kit was opened and used on the patient.There was no report of patient complication or serious injury and death.
 
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Brand Name
REDIGUARD IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8121020
MDR Text Key128959395
Report Number3010532612-2018-00367
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002679
UDI-Public00801902002679
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,foreig
Type of Report Initial,Followup
Report Date 11/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17M0036
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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