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 Codes	Inflation Problem (1310); Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after three days of therapy, the intra-aortic balloon (iab) did not inflate properly and blood was found in the iab.It was also noted that an alarm was generated and pumping stopped.A new iab was inserted to continue therapy for another two days.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
(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
N/a.
Additional Manufacturer Narrative
Visual examination of the provided photos show what appears to be dried blood inside the iab tubing.However, since the device was not returned for evaluation, we are unable to conclusively determine how dried blood entered inside the iab tubing.If the device becomes available for return, an updated evaluation will be provided.The evaluation confirmed the reported problem.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).Complaint record id # (b)(4).

• 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: jingal amin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 19616848
• Report Number: 2248146-2024-00391
• Device Sequence Number: 12290382
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: (01)10607567109718(10)3000349511(17)261114(11)231114
• 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): 11/25/2024

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 Model Number: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0480-07
• Device Lot Number: 3000349511
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 11/25/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/20/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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: UNKNOWN.
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 69 KG