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

Model Number	0684-00-0479-01U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported during insertion of the intra-aortic balloon (iab), the hub of the dilator broke off.The physician removed the dilator, opened another iab pack, proceeded with insertion, and continued initiation of therapy.There was no patient harm or adverse event reported.
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
Additional contact person: (b)(6).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Two dilators were returned with dried blood on the components.One dilator was observed to be intact with no visual defects.The dilator hub of the second dilator was observed to be broken off the from the shaft of the dilator.The hub of the dilator was observed to be slightly stripped.The broken dilator was measured and found to be within specification.No other visual defects were identified.The evaluation confirmed the reported failure the root cause of the issue at this time is impossible to define.Capa 830128 has been initiated to investigate this issue further and identify 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).

• Brand Name: LINEAR 7.5FR. 34CC IAB WITH ACCESSORIES, US ONLY
• 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: 18039189
• Report Number: 2248146-2023-00648
• Device Sequence Number: 7429218
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: (01)10607567109503(10)3000250770(17)250620(11)220621
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/06/2024

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: 06/20/2025
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0479-01U
• Device Lot Number: 3000250770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 12/22/2023; 02/02/2024; 09/06/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/22/2023; 01/09/2024; 02/02/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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 Sex: Unknown