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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 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the spring wire guide (swg) on the intra-aortic balloon (iab) couldn't pass through the catheter, after inserted into the sheath. Therefore the catheter was removed and changed for a new catheter. There was no patient death, serious injury, or complication reported. Patient current condition reported as fine.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint that the "swg couldn't pass through the catheter" is confirmed. Upon inspection, the central lumen was found damaged with kinks and flattened features. 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 that the spring wire guide (swg) on the intra-aortic balloon (iab) couldn't pass through the catheter, after inserted into the sheath. Therefore the catheter was removed and changed for a new catheter. There was no patient death, serious injury, or complication reported. Patient current condition reported as fine.
 
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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 Key7922701
MDR Text Key122197095
Report Number3010532612-2018-00300
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 09/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2018
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 Number18F17K0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
Is This a Reprocessed and Reused Single-Use Device? No

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