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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S730C
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the medical doctor that on the intra-aortic balloon (iab) the spring wire guide (swg) can't pass through the center lumen. The iab was replaced to complete the treatment. Patient outcome reported as fine. There were no reports of patient death, serious injury or complications.
 
Event Description
It was reported by the medical doctor that on the intra-aortic balloon (iab) the spring wire guide (swg) can't pass through the center lumen. The iab was replaced to complete the treatment. Patient outcome reported as fine. There were no reports of patient death, serious injury or complications.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of "swg can't pass through the central lumen" is confirmed. Upon visual inspection, numerous kinks were noted to the central lumen. Upon inserting a guidewire, resistance was experienced at the locations 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 or revised risk. This will be monitored for any developing trends. No further action required at this time.
 
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Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7671456
MDR Text Key113503884
Report Number3010532612-2018-00196
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 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberIAB-S730C
Device Lot Number18F17H0015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

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