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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 Material Split, Cut or Torn (4008)
Patient Problems Death (1802); Pulmonary Edema (2020); No Consequences Or Impact To Patient (2199)
Event Date 03/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient attended with acute pulmonary edema and decongestant measures were performed with good results. Changes were observed in cardiac enzymes and the patient underwent cardiac catheterization, where diffuse and severe atherosclerotic disease was evidenced. When the intra-aortic balloon (iab) was used for myocardial revascularization surgery, it was noted that during insertion the iab was damaged. As a result, the iab was exchanged. There was a report of patient death. Doctor (b)(6) confirmed the device did not contribute to patient death. Additional information received from the distributor that the alleged event involved the guidewire that broke by inserting the catheter.
 
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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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key8794740
MDR Text Key151188552
Report Number3010532612-2019-00242
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberIAB-S840C
Device Lot Number18F18D0041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2018
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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