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

Model Number	0684-00-0480-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (b)(6).A supplemental report will be submitted upon completion of our investigation.(reason for partial udi# - unknown serial#) complaint id# (b)(4).
Event or Problem Description
It was reported by customer that, the dilator tip of intra-aortic balloon (iab) gets destroyed over wire while pushing into the patient.
Additional Manufacturer Narrative
Updated fields - b3, b4, d9, e1 event site mail, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.All failure modes related to balloon malfunction are addressed in the risk file and there individual complaint occurrence rates are within its risk profile.The ifu addresses the mitigations for all balloon failures.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.The iab catheter is unknown based on the rational provided above, no escalation to the capa process is required.
Additional Manufacturer Narrative
Updated fields - b4, d9 date return to manufacturer, g3, g6, h2, h11 corrected field: b5, d9, h3, h6 (type of investigation, investigation findings, investigation conclusions), two introducer dilators were returned with traces of blood on the components.Additionally one step dilator was also returned with blood on the component.A visual examination of all three components were performed and no damage was observed.The reported event cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.All failure modes related to balloon malfunction are addressed in the risk file and there individual complaint occurrence rates are within its risk profile.The ifu addresses the mitigations for all balloon failures.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.The iab catheter is unknown based on the rational provided above, no escalation to the capa process is required.
Event or Problem Description
It was reported by customer that, the dilator tip of linear 40 cc intra-aortic balloon (iab) dilator tip got destroyed over wire while pushing into the patient.

• Brand Name: LINEAR 7.5FR. 40CC IAB
• 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: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 23297324
• Report Number: 2248146-2025-0000619
• Device Sequence Number: 4797981
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 01/16/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/21/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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