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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2018
Event Type  malfunction  
Manufacturer Narrative
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.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during an attempt to insert the intra-aortic balloon (iab) in the cath lab under fluoroscopy, the cardiologist found that catheter would not pass through the iliac artery.When the iab was removed it was found to be slightly unfurled.A new iab was inserted under same conditions with no issue reported.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The extender tubing was also returned.The sheath was not returned for evaluation.One kink was observed on the inner lumen within the membrane approximately 26.9cm from the iab tip.A laboratory insertion test was unable to be performed due to the kinked inner lumen and membrane being unfurled.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.The condition of the iab as received indicated a kink on the inner lumen.A kink in the inner lumen can cause difficulty during insertion.The evaluation confirmed the reported problem.We are unable to conclusively determine when this may have occurred.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.(b)(4).
 
Event Description
It was reported that during an attempt to insert the intra-aortic balloon (iab) in the cath lab under fluoroscopy, the cardiologist found that catheter would not pass through the iliac artery.When the iab was removed it was found to be slightly unfurled.A new iab was inserted under same conditions with no issue reported.There was no reported injury to the patient.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during an attempt to insert the intra-aortic balloon (iab) in the cath lab under fluoroscopy, the cardiologist found that catheter would not pass through the iliac artery.When the iab was removed it was found to be slightly unfurled.A new iab was inserted under same conditions with no issue reported.There was no reported injury to the patient.
 
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Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7934917
MDR Text Key122857589
Report Number2248146-2018-00571
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/06/2020
Device Catalogue Number0684-00-0497
Device Lot Number3000061340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2018
Device Age YR
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
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