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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
Model Number IPN000263
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion, the staff found the intra-aortic balloon (iab) was defective as it did not pass through the guidewire.As a result, the user used a new iab and inserted the iab using the same insertion site to complete the procedure.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint that the "iab catheter was found defective as it did not pass through the guidewire" is confirmed.The returned intra-aortic balloon catheter (iabc) central lumen was found kinked and resistance was noted upon passing the guidewire through the iabc central lumen.The root cause of the kinked central lumen is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that during insertion, the staff found the intra-aortic balloon (iab) was defective as it did not pass through the guidewire.As a result, the user used a new iab and inserted the iab using the same insertion site to complete the procedure.There was no report of patient complications, serious injury or 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 Key11019118
MDR Text Key221788326
Report Number3010532612-2020-00383
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002679
UDI-Public00801902002679
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,distri
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberIPN000263
Device Catalogue NumberIAB-S840C
Device Lot Number18F20A0038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Date Manufacturer Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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