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

Model Number	0684-00-0295-02
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Codes	Stroke/CVA (1770); Convulsion/Seizure (4406)
Date of Event	08/31/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Occupation: respiratory therapist.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.Complaint record id # (b)(4).
Event or Problem Description
It was reported that after approximately 14 days of intra-aortic balloon (iab) therapy, a change in patient mentation occurred including seizure activity and stroke alert.During transport, blood was seen in the helium line and the tubing was clamped.The insertion was reported to be right axillary, which is not the method described in the device instructions for use.The iab was removed and a new one was inserted in the left axillary.
Additional Manufacturer Narrative
Additional information received - outcome attributed to ae, date of death, relevant tests and lab data , type of reportable event, health effect ¿ impact codes.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1cm from the rear seal measuring 0.025cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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 sep-2019 to aug-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint (b)(4).
Event or Problem Description
It was reported that after approximately 14 days of intra-aortic balloon (iab) therapy, a change in patient mentation occurred including seizure activity and stroke alert.During transport, blood was seen in the helium line and the tubing was clamped.The insertion was reported to be right axillary, which is not the method described in the device instructions for use.The iab was removed and a new one was inserted in the left axillary.Additional information received 03-november-2021.Patient expired on(b)(6) 2021.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12515039
• Report Number: 2248146-2021-00618
• Device Sequence Number: 11008659
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: 10607567107981
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000132559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/04/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUTOCAT 2 WAVE CONSOLE; AUTOCAT 2 WAVE CONSOLE
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 61 YR
• Patient Weight: 96