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	Filling Problem (1233); Leak/Splash (1354); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: respiratory therapist.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 or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the patient had gotten up and the console began indicating that it was unable to fill and displayed negative numbers.Upon further inspection of the tubing, blood was seen in the helium line.The console was placed in standby mode and the respiratory therapist (rt) was called.The rt was able to clamp the tubing prior to the blood ever reaching the console.The iab was removed and a new iab was placed without issue.Approximately one day later, the second iab was removed after the patient received biventricular assist device (bivad) placement.There was no patient harm or adverse event reported.
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the patient had gotten up and the console began indicating that it was unable to fill and displayed negative numbers.Upon further inspection of the tubing, blood was seen in the helium line.The console was placed in standby mode and the respiratory therapist (rt) was called.The rt was able to clamp the tubing prior to the blood ever reaching the console.The iab was removed and a new iab was placed via left axillary without issue.Approximately one day later, the second iab was removed after the patient received biventricular assist device (bivad) placement.There was no patient harm or adverse event reported.First iab was inserted via right axillary.The insertion was reported to be axillary, which is not the method described in the device instructions for use.
Additional Manufacturer Narrative
Additional information - updated describe event or problem first iab was inserted via right axillary.The insertion was reported to be axillary, which is not the method described in the device instructions for use.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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.Two catheter tubing kinks were observed at 39.9cm & 76.2cm respectively.Additionally, an inner lumen break within a kink was observed within the membrane at approximately 25.4cm from the iab tip.An underwater leak test of the balloon, y-fitting, extracorporeal tubing, extender tubing and catheter tubing was performed and a leak was detected at the inner lumen break site.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and was found to be blood occluded.Unable to clear inner lumen.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane, causing the reported problem.Additionally, the occluded inner lumen could have caused the difficulty monitoring pressure.The evaluation confirmed the report problems.However, we are unable to determine when these failures may have occurred.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 jun-19 through may-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).

• 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: 11982411
• Report Number: 2248146-2021-00368
• Device Sequence Number: 16892845
• 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,Followup
• Report Date (Section B): 09/02/2021

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
• 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: 06/03/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 09/02/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/06/2021; 09/02/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUTOCAT2WAVE CONSOLE/BIVENTRICULAR ASSIST DEVICE.; AUTOCAT2WAVE CONSOLE/BIVENTRICULAR ASSIST DEVICE.
• Patient Age: 23 YR
• Patient Weight: 43