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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0513
Device Problems Migration or Expulsion of Device (1395); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2017
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: health professional. Distributor- (b)(4). Device evaluation: the product was returned with the membrane completely unfolded and clear fluid on the interior of the catheter. The guide wire was also returned. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. The technician attempted to insert the returned 0. 018¿ guide wire through the inner lumen and was able to successfully insert returned guide wire. No obstructions were felt. The iab was placed on the cs300 pump and the iab fully inflated. No alarm sounded from the pump. We are unable to confirm the reported iab migration and difficult/unable to advance guide wire because 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. Complaint # (b)(4); record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab migrated. When the guidewire was re-inserted in order to correct the iab location, the guidewire was difficult to advance. Replaced iab to continue therapy. No patient injury was reported.
 
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 during intra-aortic balloon (iab) therapy, the iab migrated. When the guidewire was re-inserted in order to correct the iab location, the guidewire was difficult to advance. Replaced iab to continue therapy. No patient injury was reported.
 
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Brand NameTRANS-RAY 7FR. 34CC IAB - JAPAN
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 Key7145224
MDR Text Key195837896
Report Number2248146-2017-00736
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2019
Device Catalogue Number0684-00-0513
Device Lot Number3000029090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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