MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0498-01
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978); Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 event site name (b)(6).Updated field b4 d9 e1 event site mail g3 g6 h2 h3 h6 type of investigation findings investigation conclusions h11.Corrected field h6 medical device problem code.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 the failure mode is addressed in the risk file and is operating within its risk profile the ifu addresses the reported failure there were no ncmrs identified which could cause or contribute to the reported failure the investigation does not indicate that the device was inadvertently released as non conforming or an adulterated product or was a counterfeit the complaint history review did not identify an adverse trend increase in number of complaints over past three 3 months based on the rational provided above no escalation to the capa process is required.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).Due to characterization limit e1: event site telephone: (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
It was reported by the customer that the intra-aortic balloon pump(iabp) guidewire bent after being inserted into the blood vessel.During the subsequent catheter replacement, the guidewire broke.A new guidewire was then used to complete the treatment.There was no patient harm or injury reported.

• Brand Name: MEGA 8FR. 50CC 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: 24219365
• Report Number: 2248146-2026-0000638
• Device Sequence Number: 9366815
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: (01)10607567107301(10)3000469255(17)280414(11)250407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133074
• 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
• Report Date (Section B): 03/02/2026

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: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0498-01
• Device Lot Number: 3000469255
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: 74 YR
• Patient Sex: Female