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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0514
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter - (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint (b)(4).Device not returned.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an acute myocardial infarction (ami) patient, the iab was unable to advance through the ascending aorta.The iab was replaced and therapy was provided.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A kink was found on the catheter tubing approximately 51.1cm from the iab tip.A laboratory insertion test was unable to be performed due to the membrane being unfurled.The technician then attempted to insert a laboratory 0.018¿ guide wire through the inner lumen of the returned iab and was successful.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Reference complaint # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an acute myocardial infarction (ami) patient, the iab was unable to advance through the ascending aorta.The iab was replaced and therapy was provided.There was no reported injury to the patient.
 
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Brand Name
TRANS-RAY 7FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8716143
MDR Text Key148542193
Report Number2248146-2019-00548
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/05/2019
Device Catalogue Number0684-00-0514
Device Lot Number3000041412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Date Manufacturer Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight72
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