MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problems Optical Problem (3001); Pressure Problem (3012)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

It was reported that after inserting the intra-aortic balloon (iab) the console generated a fiber optic sensor failure alarm and the arterial pressure could not be obtained.The arterial pressure was then obtained using the central lumen and therapy was continued without further issue.The iab was removed the next day.There was no patient harm or adverse event reported.

Manufacturer Narrative

Occupation: clinical engineer.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).H3 other text : device not returned.

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 the rear portion of the balloon.The returned sheath was not a maquet product.The one-way valve, pressure and extender tubing were also returned.A kink was found on the catheter tubing near the y-fitting approximately 73.4cm from iab tip.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and no breaks were observed along the length of the optical fiber.The evaluation confirmed the reported failure.However, we are unable to determine how this failure may have occurred and has been escalated to respective supplier to determine a root cause.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

Event Description

N/a.

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 the rear portion of the balloon.The returned sheath was not a maquet product.The one-way valve, pressure and extender tubing were also returned.A kink was found on the catheter tubing near the y-fitting approximately 73.4cm from iab tip.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and no breaks were observed along the length of the optical fiber.The evaluation confirmed the reported sensor failure.The root cause is addressed under scar 21-f-scar-14; in which it was found that the optical fiber was broken inside the connector assembly.Total preventive maintence was implemented for the eddy dispenser to establish a frequency maintenance using maximo platform.Additionally, weighing method improvement was implemented to ensure correct epoxy amount was placed into sensor cable connectors.An additional corrective action was guard installation with automatic motion on eddy dispenser to prevent take out connectors during epoxy injection cycle.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

Event Description

N/a.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC 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: 17200165
• MDR Text Key: 317857323
• Report Number: 2248146-2023-00408
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2023
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000134843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 86 YR
• Patient Sex: Male