MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-83
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) called into emergency support program line with a reoccurring gas loss alarm.She stated they were on the way to the airport to fly the patient approximately 2 hours to denver.She believed the issue was resolved after using the iab fill key and turning off the gas alarm.Esp personnel verified no blood or discoloration in the helium tubing and advised turning the gas loss alarm back on.The pump immediately alarmed gas loss and required repeated checks and iab fill to resume function.The patient was ventilated and on transport when the alarm recurred.The balloon was confirmed as an arrow 40 cc with correct 30-40 cc drive adaptor tubing already replaced.Upon arrival at the airport esp personnel outlined options to return to the hospital or continue transport with the gas alarm off per ifu since no blood was present.A screen shot showed suboptimal augmentation and atypical waveform prompting recommendation to confirm balloon placement on arrival.At 2-06 am traci confirmed the patient arrived at the cvicu at uc anshutz where placement was verified but gas loss alarms persisted on a second pump.Esp personnel advised this was likely a balloon issue and recommended teleflex troubleshooting and physician discussion with consideration for balloon replacement if alarms continued.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Other contact site telephone: (b)(6).A gas loss in the iab circuit takes place when the pump detects a helium loss due to a leak or high rate of diffusion in the iab circuit.When a cumulative shuttle gas loss exceeds a nominal 5 cc per hour dynamic limit a gas loss alarm is triggered.The alarm activates only when the iab inflation period is greater than or equal to 80 msec and the deflation period is greater than or equal to 250 msec.Gas loss cause is pump system malfunction.

• Brand Name: CARDIOSAVE RESCUE
• 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: 24853899
• Report Number: 2249723-2026-0002196
• Device Sequence Number: 18764135
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/11/2026

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: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• 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: 03/21/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: IAB ARROW 40 CC.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 101 KG