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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after less than 24 hours of therapy, the intra-aortic balloon (iab) stopped working for no apparent reason according to the doctor.A new iab was inserted with meticulous placement.Consequently, the second iab ruptured with blood backing up to the cardiosave intra-aortic balloon pump (iabp).Service logs from the iabp indicated that catheter restriction and gas loss in iab circuit alarms were generated.There was no patient harm or adverse event reported.This record is for the 2nd iab used.A separate report has been submitted for the 1st iab under mfg report number 2248146-2023-00358.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-02388.
Additional Manufacturer Narrative
Complete reporter name: (b)(6).Additional email address: (b)(6).Complete event site name: (b)(6).Event site postal code: (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).H3 other text: device not returned.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An iab service technician log was provided by the facility.The log shows record of the alarms.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, the reported leak could not be confirmed.Based on the provided log, the reported alarms were confirmed.However, we were unable to confirm or determine a root cause for the reported failure.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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17034561
• Report Number: 2248146-2023-00359
• Device Sequence Number: 6412834
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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 Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: UNKNOWN
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/14/2023
• 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
• Patient Sex: Unknown