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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 Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the guidewire was not able to be inserted. The staff noted that the guidewire was kinked. As a result, the device was replaced, and another attempt was made with a new guidewire successfully. There was no report of patient death, serious injury or complications.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the guidewire was not able to be inserted. The staff noted that the guidewire was kinked. As a result, the device was replaced, and another attempt was made with a new guidewire successfully. There was no report of patient death, serious injury or complications.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint that the "guidewire was kinked" is confirmed based on the customer picture provided with the complaint report. The picture indicates that the guidewire was kinked. The root cause of the complaint is undetermined. If the product is returned at a later date, a full investigation of the sample will be completed. 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. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8214039
MDR Text Key131973085
Report Number3010532612-2018-00409
Device Sequence Number1
Product Code DSP
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 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F18A0001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

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