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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 10/17/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported there was big resistance when the intra-aortic balloon (iab) catheter was implanted along the spring wire guide (swg) into the sheath. The swg was deformed, and the balloon was damaged. Then replacing with another catheter, there was big resistance as well, but it can go into the body reluctantly, and the device began to work. There was no patient death or serious injury or reported. Patient current condition reported as fine.
 
Event Description
It was reported there was big resistance when the intra-aortic balloon (iab) catheter was implanted along the spring wire guide (swg) into the sheath. The swg was deformed, and the balloon was damaged. Then replacing with another catheter, there was big resistance as well, but it can go into the body reluctantly, and the device began to work. There was no patient death or serious injury or reported. Patient current condition reported as fine.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of insertion difficulty is not able to be confirmed. The root cause of the complaint 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. 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 Key8080956
MDR Text Key127551252
Report Number3010532612-2018-00369
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 10/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17L0006
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

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