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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Difficult to Insert (1316); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2017
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.(b)(4).
 
Event Description
It was reported that while using a 23cm 8fr cordis sheath, into right groin, the intra-aortic balloon (iab) catheter was advanced over the wire, but had resistance and could not be inserted fully.The iab was prepped and pulled negative 2 times before reaching the patient.Dr.Did not feel comfortable using this balloon, and replaced with a new iab.There was no injury or harm 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.(b)(4).
 
Event Description
It was reported that while using a 23cm 8fr cordis sheath, into right groin, the intra-aortic balloon (iab) catheter was advanced over the wire, but had resistance and could not be inserted fully.The iab was prepped and pulled negative 2 times before reaching the patient.Dr.Did not feel comfortable using this balloon, and replaced with a new iab.There was no injury or harm to the patient.
 
Manufacturer Narrative
Additional info: reporter's phone number is (b)(6), it was inadvertently not submitted in initial mdr report.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.The sheath was not returned for evaluation.The catheter tubing was observed to be flattened along its length.This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape.Two kinks were found on the catheter tubing near the y-fitting approximately 75.2cm and 76.2cm from the iab tip.A laboratory insertion test was unable to be performed due to the 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.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.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.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.Complaint # (b)(4).
 
Event Description
It was reported that while using a 23cm 8fr competitor's sheath, into right groin, the intra-aortic balloon (iab) catheter was advanced over the wire, but had resistance and could not be inserted fully.The iab was prepped and pulled negative 2 times before reaching the patient.Dr.Did not feel comfortable using this balloon, and replaced with a new iab.There was no injury or harm to the patient.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6937601
MDR Text Key90186915
Report Number2248146-2017-00450
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/18/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000049924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age70 YR
Patient Weight72
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