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 Problem Difficult to Advance (2920)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported that the customer attempted to insert the intra-aortic balloon (iab) using another manufacturer's sheath.When they tried to apply negative pressure with a one-way valve, no negative pressure was applied to the gas lumen and the iab could not be inserted.A new iab was successfully inserted.There was no patient harm or adverse event reported.

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.(b)(4).

Manufacturer Narrative

Updated fields: b4, d10, g4, h3, h6, h10.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 on the exterior of the catheter.The syringe and one-way valve were also returned separate from the iab.A catheter tubing kink was observed near the y-fitting at approximately 75.9cm from the iab tip.An additional inner lumen kink was also observed within the membrane at approximately 18.3cm from the iab tip.The one-way valve was tested and held vacuum a 0.025¿ laboratory guidewire was inserted through the inner lumen and was found to be occluded with dry blood.Unable to clear the occlusion.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.Kinks along the length of the inner lumen can cause difficulty inserting the iab through the sheath.However, we were unable to determine how this kink may have occurred.Unable to duplicate the clinical settings.The evaluation confirmed the reported problem.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).

• 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: 13770270
• MDR Text Key: 288797273
• Report Number: 2248146-2022-00216
• 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: Physician
• Type of Report: Followup,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000137769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO 8FR SHEATH.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 95 KG