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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0514
Device Problems Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2019
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) insertion, the customer found a kink in the iab shaft.The iab catheter was unable to be advanced to the proper position.The iab was replaced to continue therapy.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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the customer found a kink in the iab shaft.The iab catheter was unable to be advanced to the proper position.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information - serial # - (b)(4).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 id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the customer found a kink in the iab shaft.The iab catheter was unable to be advanced to the proper position.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.One kink was found on the inner lumen approximately 25.4cm from the iab tip.An additional 3 kinks were found on the catheter tubing approximately 39.1, 46.7 & 76.2cm from the iab tip.The technician attempted to insert a 0.018¿ laboratory guide wire through the inner lumen.Due to a blood occlusion, the guide wire was not able to reach the kink location.The condition of the iab as received indicated kinks on the catheter tubing and inner lumen.We are unable to determine when the kink may have occurred.Kinks on the inner lumen can cause difficulty during iab insertion.The evaluation confirmed the reported problem.A device and lot history record review and trend evaluation was completed for the reported product.No nonconformances were found that are considered to be related to the event.Record id: (b)(4).Autonumber: (b)(4).S/n: (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the customer found a kink in the iab shaft.The iab catheter was unable to be advanced to the proper position.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8509350
MDR Text Key142521803
Report Number2248146-2019-00294
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2021
Device Catalogue Number0684-00-0514
Device Lot Number3000076277
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Device Age YR
Initial Date Manufacturer Received 03/26/2019
Initial Date FDA Received04/12/2019
Supplement Dates Manufacturer Received05/14/2019
06/14/2019
08/12/2019
Supplement Dates FDA Received05/31/2019
07/12/2019
08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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