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 11/12/2021

Event Type  malfunction  

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.Complaint record id # (b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the iab could not be advanced to the optimal position.A new iab was inserted successfully to continue therapy.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 loosely folded with traces of blood on the exterior of the catheter.The one-way valve was also returned.A catheter tubing/inner lumen kink was observed near the y-fitting at approximately 68.3cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The one-way valve was vacuum tested and it held vacuum.A 0.025¿ laboratory guidewire was inserted through the inner lumen and obstruction was felt at the kink location.A laboratory insertion test was unable to be performed due to the returned condition of the iab.The evaluation found a catheter kink which could cause difficulty inserting the iab.However, we were unable to determine when this kink may have occurred.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: 12942998
• MDR Text Key: 285986164
• Report Number: 2248146-2021-00826
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000125561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Prefer Not To Disclose