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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problems Unraveled Material (1664); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
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. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, intra-aortic balloon (iab) was difficult to advance through the sheath. Customer mentioned that they used other commercially available sheath. Guidewire was successfully inserted. It was noted that during insertion of iab catheter, iab balloon membrane became unfurled. Intra-aortic balloon (iab) was replaced to continue therapy. No patient injury was reported.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 35CC IAB
Type of DeviceSYSTEM, 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 Key8038393
MDR Text Key126529226
Report Number2248146-2018-00628
Device Sequence Number0
Product Code DSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2021
Device Catalogue Number0684-00-0604
Device Lot Number3000075438
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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