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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
Model Number IPN000262
Device Problems Difficult to Insert (1316); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Other remarks: see mdr# 3010532612-2020-00354 (tc 1900080711) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) dispersed during insertion, which made it difficult to insert.As a result, another iab was used and inserted using the same insertion site.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint iab unwrapped prematurely is confirmed.The one-way valve failed during functional testing.A failing one-way valve will result in difficulty of pulling and maintaining a vacuum on the iab bladder.If a vacuum of the bladder is not maintained, it can result in insertion difficulty.The iab bladder membrane passed functional testing.The root cause of the complaint is undetermined.A potential cause is user related due to the dried media on the valve seal.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.Other remarks: see mdr# 3010532612-2020-00354 (tc 1900080711) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) dispersed during insertion, which made it difficult to insert.As a result, another iab was used and inserted using the same insertion site.There was no report of patient complications, serious injury or death.
 
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Brand Name
REDIGUARD IAB: 7FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10856064
MDR Text Key217361299
Report Number3010532612-2020-00368
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002686
UDI-Public00801902002686
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 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F20B0028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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