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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 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the catheter could not get through the supplied guide wire during intra-aortic balloon (iab) insertion.As a result, the surgeon opened another iab kit to complete the procedure.There was no report of delay in therapy, there was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.The returned iab central lumen was found kinked and resistance was noted upon loading the guidewire into the central lumen.The root cause of the kink is undetermined but a potential cause is a result of 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 revised risks.This will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that the catheter could not get through the supplied guide wire during intra-aortic balloon (iab) insertion.As a result, the surgeon opened another iab kit to complete the procedure.There was no report of delay in therapy, 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 Key8579140
MDR Text Key144007273
Report Number3010532612-2019-00126
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,foreig
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F18A0011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Initial Date Manufacturer Received 04/17/2019
Initial Date FDA Received05/03/2019
Supplement Dates Manufacturer Received06/13/2019
Supplement Dates FDA Received06/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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