MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-65
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use the cs300 cardiosave intra-aortic balloon pump (iabp) experienced a balloon rupture while using a trp4046 catheter.The procedure was completed successfully with a replacement balloon, and there was no patient harm or injury reported.
Additional Manufacturer Narrative
Due to character limit: e1 (event site address) - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (medical device problem code and type of investigation).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).Updated field: b4, b5, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that a check for blood draw in was performed.Since the event occurred before automatic filling began no blood had been drawn into the device.Per the fse no repair work was required.
Event or Problem Description
It was reported that during use the cs300 intra-aortic balloon pump (iabp) experienced a balloon rupture while using a trp4046 catheter.The procedure was completed successfully with a replacement balloon, and there was no patient harm or injury reported.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 24091882
• Report Number: 2249723-2026-0000508
• Device Sequence Number: 21392027
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: (01)10607567108322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/12/2026; 04/03/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/15/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSRAY PLUS 40 CC IAB.
• Patient Sex: Male