MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number	0684-00-0474
Medical Device Problem Codes	Inability to Auto-Fill (1044); Inflation Problem (1310)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/14/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Occupation: senior biomed lead.Additional reporter: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Reference complaint (b)(4).
Event or Problem Description
It was reported that an intra-aortic balloon (iab) was being inserted to assist with weaning the patient from bypass following a valve procedure.During therapy, the cardiosave intra-aortic balloon pump (iabp) generated an autofill failure alarm and the iab would not inflate.A new iab was inserted but the same issue occurred.At the time of attempting to initiate therapy, it was noted that the patient had adequate electrocardiogram (ekg) signal to the iabp and fluid-filled transducer was set up.There were not any significant issues with insertion.They did not perform a manual fill at the time of initiation for either iab and they did not attempt to use another iabp.However, the technician did separate the second catheter from the helium tubing and felt helium flowing out of the helium extender tubing.It was also noted that when the second iab was removed, there was dried blood observed on the catheter and when inflation was attempted it was somewhat stuck together.Following the failure to initiate iab support, the patient was then placed on extracorporeal life support (ecls) and taken from the operating room (or) for a short period of time.Bleeding was suspected as the patient decompensated.The patient was then brought back to the or, placed on bypass again, and the procedure was repeated/escalated to total replacement of the valve in question.Bleeding was confirmed, at that time, and the necessity to redo the procedure.The physician decided not to place patient on ecls again, or attempt another iab.The patient was scheduled to be transferred to another facility, but the tertiary care facility would not accept the patient since they were not on ecls support.Patient was then transferred to the icu where they expired shortly after.This report is for the 1st iab used in this event.A separate report will be submitted for the 2nd iab.An additional report for the cardiosave iabp used in this event has been submitted under mfg report number 2249723-2023-03813.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 17693442
• Report Number: 2248146-2023-00550
• Device Sequence Number: 5981400
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: 10607567106557
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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 Catalogue Number: 0684-00-0474
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CARDIOSAVE / CH279397E8
• Outcome Attributed to Adverse Event: Death
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 126 KG