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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE LACIOTAT LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE LACIOTAT LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problems Crack (1135); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2017
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.We continue our efforts to follow up with the customer for its return.(b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy it was noted that there was a crack a the iab.The customer also noted that there was an alarm for blood in balloon.The iab had to be replaced in order to continue therapy.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 during intra-aortic balloon (iab) therapy it was noted that there was a crack a the iab.The customer also noted that there was an alarm for blood in balloon.The iab had to be replaced in order to continue therapy.There was no injury or harm to the patient.
 
Manufacturer Narrative
Phone number of reporter: (b)(6).The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter.Dried blood was found occluding the inner lumen.The occlusion was able to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.5cm from the rear seal measuring 0.05cm in length.The reported blood in tubing & alarm was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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 during intra-aortic balloon (iab) therapy it was noted that there was a crack a the iab.The customer also noted that there was an alarm for blood in balloon.The iab had to be replaced in order to continue therapy.There was no injury or harm to the patient.
 
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Brand Name
LINEAR 7.5 FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE LACIOTAT
zi athelia 1
la ciotat cedex NJ 13705
FR  13705
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6758578
MDR Text Key81720981
Report Number2248146-2017-00197
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBG
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/08/2018
Device Catalogue Number0684-00-0474
Device Lot Number3000011039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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