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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 12/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that in the cath lab an intra-aortic balloon catheter (iabc) was tried with a new balloon but unable to negotiate on sheath because balloon was kinked. As a result, a new kit was used. There was a report of delay in therapy. There was no report of patient complication or serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iab kinked is not able to be confirmed. 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. This will be monitored for any developing trends. No further action required at this time. Other remarks: the reported complaint has been reopened to investigate the device that was returned to teleflex for investigation. The reported complaint of iab kinked is confirmed. Several kinks were noted on the returned iab's central lumen near the proximal end of the iab bladder during the complaint investigation. The root cause of how the central lumen became kinked is undetermined. A potential cause is user 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 risk. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that in the cath lab an intra-aortic balloon catheter (iabc) was tried with a new balloon but unable to negotiate on sheath because balloon was kinked. As a result, a new kit was used. There was a report of delay in therapy. There was no report of patient complication or serious injury or death.
 
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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 Key8391425
MDR Text Key137858362
Report Number3010532612-2019-00056
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,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2019
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 Number18F18A0011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No

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