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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 09/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported during insertion of the intra-aortic balloon (iab) "the guide does not advance through the light of the ball, it is finally possible to advance and positioned properly, but the ball does not give the pressure wave, despite washing several times the internal light and advancing the guide there is no wave or pressure record, so it is decided to change the iab. " there was no patient death or serious injury or reported.
 
Manufacturer Narrative
Qn# (b)(4). Teleflex received the device for investigation. The reported complaint that the "guide does not advance" is confirmed. Upon inspection, the central lumen was found damaged with kinks. Upon inserting a guidewire, resistance was experienced at the location of the kinks. The root cause of the kinks 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. No further action required at this time.
 
Event Description
It was reported during insertion of the intra-aortic balloon (iab) "the guide does not advance through the light of the ball, it is finally possible to advance and positioned properly, but the ball does not give the pressure wave, despite washing several times the internal light and advancing the guide there is no wave or pressure record, so it is decided to change the iab. " there was no patient death or serious injury or reported.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7942723
MDR Text Key123373082
Report Number3010532612-2018-00310
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17K0032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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