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

Model Number	0684-00-0479-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak occurred during intra-aortic balloon (iab) therapy.Blood was noted inside the external extension tubing as well as inside the cs300 intra-aortic balloon pump (iabp) circuit.A new iab was inserted and the iabp was replaced with another to continue therapy.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 cs300 iabp under mfg report number 2249723-2024-00379.
Additional Manufacturer Narrative
(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.Complaint record id # (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).
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).Reference complaint # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 34CC IAB (WITH APA)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18653765
• Report Number: 2248146-2024-00076
• Device Sequence Number: 15502028
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000307165(17)260509(11)230509
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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: 05/09/2026
• Device Model Number: 0684-00-0479-02
• Device Catalogue Number: 0684-00-0479-02
• Device Lot Number: 3000307165
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 10/10/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/05/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2023
• 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: CS300
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 78 KG