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

Model Number	0684-00-0480-07
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after approximately 30 hours of intra-aortic balloon (iab) therapy, blood was seen inside the tubing.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site postal code - (b)(6).Additional email address: (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 # 947673 h3 other text : device not returned.
Additional Manufacturer Narrative
Photographs were provided by the facility.The photograph shows the iab with the membrane completely unfolded and blood on the interior and exterior of the catheter tubing and membrane.No decon or visual inspection performed since product was not returned and could not be evaluated.Based on the photographic evidence provided by the facility, the reported failure "leak, blood in tubing" is confirmed.However, since the product was not returned, we were unable to evaluate the device.Therefore, we are unable to determine a root cause.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
Event or Problem Description
N/a.
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).Complaint record id (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 40CC IAB (INDIA)
• 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: 18430872
• Report Number: 2248146-2024-00008
• Device Sequence Number: 12805424
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: (01)10607567109718(10)3000315476(17)260615(11)230615
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/15/2024

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: 06/15/2026
• Device Model Number: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0480-07
• Device Lot Number: 3000315476
• 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: 12/15/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 10/15/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/11/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 75 KG