MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0295-01

Device Problems Filling Problem (1233); Off-Label Use (1494)

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

Event Date 04/04/2021

Event Type  malfunction  

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

It was reported that during intra-aortic balloon (iab) therapy, the console indicated that there was an auto-fill failure.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer attempted another auto-fill without relief.There was no visible blood or kinks in the tubing.The customer was not interested in manually filling the iab.A chest x-ray was advised to confirm the location of the iab.Upon follow up, the customer had removed the iab and replaced it with a new one also via axillary insertion.There was no patient harm or adverse event reported.

Manufacturer Narrative

The iab was returned cut in two parts with the membrane completely unfolded and blood on the interior and exterior of the catheter and within the stat gard sleeve.The extracorporeal tubing was cut from the iab and not returned.A kink was found on the catheter tubing and inner lumen approximately 0.3cm from the y-fitting.An underwater leak test of the balloon, catheter and y-fitting was performed and a leak was observed on the catheter tubing at the kinked location.The penetration found in the catheter tubing appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing causing the reported problem.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall complaint trend data for the period may-19 to apr-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).

Event Description

N/a.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11706129
• MDR Text Key: 246977709
• Report Number: 2248146-2021-00250
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (y/n): N
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000116949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 04/04/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 07/16/2021
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 78