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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the guidewire not going through the balloon. As a result, a new catheter was inserted at the same insertion site. There was a report of patient death; however, doctor (b)(6) made the medical judgement that the device did not cause or contribute to the patient's death.
 
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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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key12549224
MDR Text Key273889068
Report Number3010532612-2021-00313
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
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 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000263
Device Catalogue NumberIAB-S840C
Device Lot Number18F20J0046
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2020
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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