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 Restricted Flow rate (1248); Off-Label Use (1494); Material Deformation (2976)

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

Event Date 06/03/2021

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 generated a constant catheter restriction alarm.The console was swapped out for a different one but the issue continued.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was made aware of the off-label use and continued to troubleshoot as though the insertion was femoral.It was confirmed that there were no external kinks in the helium tubing and all connections were secure.The customer attempted to use the fill key several times with no success.The customer was advised that there may be an internal kink and arranged to have the iab removed.There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A portion of the extracorporeal tubing cut from the iab and not returned.A kink was found on the inner lumen and catheter tubing near the y-fitting approximately 76.5cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was observed at the kinked location on the catheter tubing.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 problems.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.The evaluation confirmed the reported problems.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period jul-19 to jun-21 was reviewed.Communication/interviews: (4111/213) 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: 12060662
• MDR Text Key: 259698026
• Report Number: 2248146-2021-00409
• 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: 09/15/2021

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: 06/09/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/15/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 56 YR
• Patient Weight: 61