MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-02
Medical Device Problem Codes	Inability to Auto-Fill (1044); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after approximately two hours of intra-aortic balloon (iab) therapy, blood was seen in the helium tubing and into the cardiosave intra-aortic balloon pump (iabp).Pumping stopped suddenly without any audible alarms.The iab was removed.A replacement iab was not inserted because the patient maintained a stable condition after removal.It was noted that the iabp alarm log indicated catheter restriction and autofill failure alarms.There was no patient harm or adverse event reported.This report is for the iab involved in this event.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2023-04675.
Additional Manufacturer Narrative
Complete initial reporter name - (b)(6).Additional initial reporter 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.(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.
Additional Manufacturer Narrative
Udi related data quality updates only: complaint record id # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 40CC IAB (WITH APA)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18086218
• Report Number: 2248146-2023-00660
• Device Sequence Number: 15110337
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: (01)10607567106571(10)3000307163(17)260504(11)230504
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K041281
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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: 05/04/2026
• Device Model Number: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0480-02
• Device Lot Number: 3000307163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 08/23/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/30/2023; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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 / (B)(6).
• Patient Age: 78 YR
• Patient Sex: Female