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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 Deformation Due to Compressive Stress (2889)
Patient Problems Death (1802); Renal Disease, End Stage (2039); Perforation of Vessels (2135)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted after puncture, it was noted that the balloon was kinked at the front end of the blood vessel which caused damage of the front end of the blood vessel. The blood vessel was repaired by the vascular surgery doctor. As a result, the catheter was removed, and a second attempt was made successfully with a new catheter. Patient outcome reported as fine. There was no report of patient death.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted after puncture, it was noted that the balloon was kinked at the front end of the blood vessel which caused damage of the front end of the blood vessel. The blood vessel was repaired by the vascular surgery doctor. As a result, the catheter was removed, and a second attempt was made successfully with a new catheter. Patient outcome reported as fine. There was no report of patient death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iab kinked is not able to be confirmed. No kinks, bends or damage was noted on the returned iab during the complaint investigation. The returned device passed visual and functional test specifications. The root cause of the complaint is undetermined. Potential causes are patient condition and insertion technique. No further action required at this time. 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. Other remarks: additional information received. On (b)(6) 2019, the balloon was inserted after puncture, then the balloon was found kinked at the front end of the blood vessel, which caused the damage of the front end of the blood vessel. Then the blood vessel was repaired by the vascular surgery doctor. Then the new catheter was re-inserted successfully at the opposite site. Some days later, the patient died as his physical condition- renal failure. The dr. (b)(6) judged it was not our device which caused the death, as the death was caused by the patient's physical condition.
 
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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 Key8349738
MDR Text Key136467506
Report Number3010532612-2019-00024
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 01/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17L0006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Is This a Reprocessed and Reused Single-Use Device? No

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