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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANSRAY PLUS 7.5 FR. 35CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANSRAY PLUS 7.5 FR. 35CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 record id # (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the iab could not be advanced.The iab was removed and a second iab was inserted without issue and therapy was completed successfully.There was no reported injury to the patient.
 
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.Reference complaint # (b)(4).Device not returned.
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the iab could not be advanced.The iab was removed and a second iab was inserted without issue and therapy was completed successfully.There was no reported injury to the patient.
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the iab could not be advanced.The iab was removed and a second iab was inserted without issue and therapy was completed successfully.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The sheath was not returned for evaluation.The sensor connector and portion of cable was cut from the iab and not returned.One kink was found on the catheter tubing and inner lumen near the y-fitting approximately 73.9 cm from the iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.A laboratory insertion test was unable to be performed due to the membrane being unfurled and the catheter and inner lumen kinked.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The condition of the iab as received indicated a kink on the catheter tubing and inner lumen.A kink in the inner lumen can cause difficulty during insertion.We are unable to determine when the kink may have occurred.The evaluation confirmed the reported problem.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #: (b)(4).
 
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.Reference complaint #(b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the iab could not be advanced.The iab was removed and a second iab was inserted without issue and therapy was completed successfully.There was no reported injury to the patient.
 
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Brand Name
TRANSRAY PLUS 7.5 FR. 35CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10684893
MDR Text Key219524732
Report Number2248146-2020-00540
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 01/27/2021
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 Date02/26/2023
Device Catalogue Number0684-00-0604
Device Lot Number3000115653
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Initial Date Manufacturer Received 09/25/2020
Initial Date FDA Received10/15/2020
Supplement Dates Manufacturer Received11/11/2020
01/05/2021
01/27/2021
Supplement Dates FDA Received11/11/2020
01/26/2021
01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age91 YR
Patient Weight45
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