MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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.

• 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 Key: 12699078
• MDR Text Key: 278408066
• Report Number: 2248146-2021-00703
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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 Date: 04/27/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000119351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 01/24/2022; 02/16/2022
• Supplement Dates FDA Received: 02/08/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.