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 Filling Problem (1233); Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

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 during intra-aortic balloon (iab) therapy, the console indicated that catheter inspection was required.It was also indicated that there was a leak in the iab circuit, blood detected, an auto-fill failure, and the optical sensor was unable to calibrate.The iab was removed.There was no patient harm or adverse event reported.

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).

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood traces only on the statguard.The returned maquet sheath was located at 35.3cm from the iab tip.The stopcock, extender tubing and pressure tubing were also returned.An inner lumen kink, catheter tubing kink and optical fiber breakage were observed at 35.3cm from the iab tip.A leak test of the balloon, catheter, pressure tubing, y-fitting, extracorporeal tubing and extender tubing was performed and no leaks were detected.A guidewire was then inserted into the inner lumen.There was a smooth insertion with an obstruction at the inner lumen kink location and blood traces were found on the guidewire.The iab was placed on a cs300 pump for two hours which represents one complete autofill cycle.The iab pumped normally, no alarm sounded.The optical fiber was found to be broken, confirming the reported failure "difficult/unable to calibrate optical sensor".However, the reported alarms "autofill failure, "check iab catheter", "blood detected" and "leak in circuit" were not confirmed as there were no leaks and the iab pumped normally.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 may-2019 through apr-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: 11738731
• MDR Text Key: 247898869
• Report Number: 2248146-2021-00269
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000127406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300 SI251176H4).