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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 0684-00-0605
Device Problems Optical Problem (3001); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (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 immediately after insertion of the intra-aortic balloon (iab), the fiber optic sensor stopped working and the message optical sensor failure was displayed on the monitor.The customer monitored the patient's blood pressure manually.Additionally, a leak alarm was generated every hour.It was also noted that the statlock prep pad was dry and could not be used.Therapy was successful using the same iab catheter throughout.There was no patient harm or adverse event reported.
 
Event Description
N/a.
 
Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering half of the balloon.The sheath sideport tubing was cut from the sheath and not returned.Two kinks were found on the catheter tubing and inner lumen approximately 71.9cm and 76.2cm from the iab tip.The optical fiber was found to be broken at the kinked location of 71.9cm.Additionally a third kink was found on the inner lumen within the membrane approximately 23.4cm from the iab tip.The optical fiber was found to be broken at this location.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was observed at the kinked location of 71.9cm on the catheter tubing.The penetration found in the catheter tubing appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing and breaking the optical fiber.The evaluation confirmed the reported problems.We are unable to determine when this may have occurred.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-2019 to oct-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).
 
Event Description
N/a.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12699078
MDR Text Key278408066
Report Number2248146-2021-00703
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/16/2022
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 Date04/27/2023
Device Catalogue Number0684-00-0605
Device Lot Number3000119351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/05/2021
Initial Date FDA Received10/26/2021
Supplement Dates Manufacturer Received01/24/2022
02/16/2022
Supplement Dates FDA Received02/08/2022
02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN.
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