MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Material Deformation (2976); Pressure Problem (3012)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Reference complaint #: (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, there was a high pressure alarm on a non-getinge pump while using a getinge iab.The customer was asked to check for any kinking in the iab catheter and to take a chest x-ray to check positioning of the iab.There was no patient harm or adverse event reported.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.A kink was found on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from the iab tip.A second kink was found on the catheter tubing approximately 59.2cm 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 iab was placed on the cardiosave pump and the iab fully inflated and deflated.The iab then pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The condition of the iab as received indicated kinks in the catheter tubing.It is difficult to determine when or how a kink in the catheter occurs.The evaluation confirmed the reported kink however the reported gas alarm cannot be confirmed by the evaluation.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: MEGA 8FR. 50CC 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: 18975056
• MDR Text Key: 338568483
• Report Number: 2248146-2024-00171
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: 10607567107301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000308474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARROW/TELEFLEX BALLOON PUMP