MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID TYPE M PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-35
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an angiogram, and an intra-aortic balloon (iab) catheter was inserted for therapy with cardiosave intra-aortic balloon pump (iabp) unit.The following day, blood was observed in the helium tubing while the patient was being repositioned.The pump continued to operate without generating any alarms.The pump was placed in standby, and the helium tubing was clamped.An attempt to remove the catheter was unsuccessful, requiring surgical removal.A large clot was identified during the procedure, and an additional 5 cm groin incision was required to facilitate catheter removal.The patient remained stable following the procedure.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID TYPE M PLUG
• 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: 50067333
• Report Number: 2249723-2026-0003646
• Device Sequence Number: 10481244
• Product Code: DSP
• UDI-Device Identifier: 10607567109107
• UDI-Public: (01)10607567109107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2018
• 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: Intra-Aortic Balloon (b)(4)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 162 LB