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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problems Decrease in Pressure (1490); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter was prepped per directions, after pulling negative pressure and removing the catheter from the package.The balloon was bunched up at the tip of the catheter as well as the base of the catheter.The doctor tried inserting the iab into the patient with no success.The balloon became floppy and the md could not place the balloon into the body, therefore another iab was used.There were no report of patient complications, serious injuries or death.
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter was prepped per directions, after pulling negative pressure and removing the catheter from the package.The balloon was bunched up at the tip of the catheter as well as the base of the catheter.The doctor tried inserting the iab into the patient with no success.The balloon became floppy and the md could not place the balloon into the body, therefore another iab was used.There were no report of patient complications, serious injuries or death.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab balloon damaged is not confirmed.The returned iab bladder was fully intact with no abnormalities noted.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8836047
MDR Text Key152516214
Report Number3010532612-2019-00227
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberIAB-06840-U
Device Lot Number18F19B0014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Date Manufacturer Received08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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