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

Model Number	0684-00-0296-02
Medical Device Problem Codes	Leak/Splash (1354); Inappropriate Waveform (2536); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been transferred from another facility with an impella device inserted in the left groin.The impella device was removed due to left lower leg ischemia (subsequent repair of left femoral artery).The customer attempted to insert another impella device in the right axillary but this was unsuccessful due to a tortuous aorta.The customer then inserted a maquet intra-aortic balloon (iab).The insertion was reported to be right axillary, which is not the method described in the device instructions for use.After insertion of the iab, the waveform was dampened.Approximately four hours later, the waveform was flat.Approximately three and a half hours after that, blood was seen in the tubing.It was noted that the console had generated a gas loss in iab circuit alarm on several occasions.The iab was removed soon after the blood was noticed.The patient was extubated and progressing after therapy was concluded.There was no patient harm or adverse event reported.
Additional 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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior and interior of the catheter, between the sheath and catheter tubing.A kink was observed on the catheter tubing approximately 8.1 cm from the y-fitting.The sheath was returned attached approximately 60.9cm from the iab tip.The inner lumen was found to be occluded.The occlusion was able to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing, extender tubing, and pressure tubing was performed and a leak was detected approximately 3.0cm from the rear seal.The reported events was confirmed by the evaluation.The observed leak was a penetration within a whitish patch.The patch exhibited the typical appearance of an abrasion mark caused by calcified plaque in the aorta.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 reported failure.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
Event or Problem Description
N/a.

• Brand Name: MEGA 8FR. 50CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 14701430
• Report Number: 2248146-2022-00474
• Device Sequence Number: 5075068
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: 10607567108018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 12/06/2024
• Device Model Number: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000209759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUTOCAT WAVE CONSOLEIMPELLA CATHETER
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG