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

Model Number 0684-00-0296-01

Device Problem Insufficient Information (3190)

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

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 there was an intra-aortic balloon (iab) failure.There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior.No damaged was observed on the iab catheter.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 cs300 pump and the iab fully inflated.No alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.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.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 apr-19 to mar-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).

• 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
• MDR Report Key: 11693072
• MDR Text Key: 247001258
• Report Number: 2248146-2021-00241
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: 10607567108001
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• 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

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000093891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 07/16/2021
• Patient Sequence Number: 1
• Patient Age: 76 YR