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

Model Number	0684-00-0295-01
Medical Device Problem Codes	Device Alarm System (1012); Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Initial reporter full name: (b)(6).Additional reporter information: (b)(6), director of risk management, patient safety, accreditation, regulation & licensing, and infection prevention / (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id #: (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, an iab rupture occurred with blood backing up into helium tubing.The customer was unable to provide further information regarding alarms or clinical situation.The critical patient was unable to be support with therapy and had to be resuscitated.Reported via medwatch report # mw5117071 received 03may2023: while patient was in intensive care unit blood was noted in the intra-aortic balloon pump helium line, which had been in place for 23 hours, requiring immediate shut off of device.Patient suffered cardiac arrest leading to thrombosis, inadequate perfusion, family decision to place on comfort care, and death.This report is for the iab.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-02149.
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, an iab rupture occurred with blood backing up into helium tubing.The customer was unable to provide further information regarding alarms or clinical situation.The critical patient was unable to be support with therapy and had to be resuscitated.Reported via medwatch report #mw5117071 received 03may2023: while patient was in intensive care unit blood was noted in the intra-aortic balloon pump helium line, which had been in place for 23 hours, requiring immediate shut off of device.Patient suffered cardiac arrest leading to thrombosis, inadequate perfusion, family decision to place on comfort care, and death.Received on 10may2023: 82f presented to outside hospital, found to have nstemi, transported to (b)(6).Patient found to have left main disease and multivessel cad during (b)(6) 2023 cardiac cath; 40cc iabp placed for chest pain during pci.Patient transferred to icu and was in stable condition.No complications noted during placement or during pumping.On (b)(6) 2023, about 22 hours after insertion, the machine showed an ¿iab catheter restriction¿ alarm and when the rn assessed for a kink in the line, she visualized blood in the line, then immediately disabled iabp function.
Additional Manufacturer Narrative
Additional reporter: (b)(6).Reference complaint #(b)(4).
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
Event or Problem Description
N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16916007
• Report Number: 2248146-2023-00326
• Device Sequence Number: 20438782
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023

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 Expiration Date: 01/03/2026
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000288436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 07/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 05/30/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2023
• 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 / CH254265D7
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Female