MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01
Medical Device Problem Codes	Signal Artifact/Noise (1036); Difficult to Flush (1251); Migration or Expulsion of Device (1395); Pacing Problem (1439); Infusion or Flow Problem (2964); Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (initial reporter: (b)(6)).Additional reporter information: (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 id# (b)(4).
Event or Problem Description
It was reported that during use, the console screen of the intra-aortic balloon (iab) revealed artifact present in the ecg and it was also reported that iab catheter was unable to aspirate the inner lumen.No harm reported.
Additional Manufacturer Narrative
Other contact email: (b)(6).Updated field: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field: b5, g2, h6 medical device problem code.A customer called the emergency support program, generating two complaints: (b)(4) (catheter) and (b)(4) (pump).(b)(6), a cticu rn, reported repeated ¿unable to update timing¿ alarms on a cardiosave pump despite replacing electrodes and flushing the line.Troubleshooting identified ecg artifact and catheter whip in the arterial waveform, though no active alarms or patient harm were noted.Further review revealed the catheter tip was positioned around the 7th¿8th rib, outside the recommended location of the 2nd¿3rd intercostal space.Attempts by the pa to aspirate the inner lumen were unsuccessful, though they believed placement appeared acceptable.Support staff reinforced correct placement guidelines and recommended capping the inner lumen and transitioning to another arterial waveform source.Instructions were provided to the charge nurse, and recommendations were reviewed with (b)(6), who acknowledged and appreciated the guidance.Based on the event description, the underlying cause of the reported ¿unable to update timing¿ alarm was improper catheter positioning, as the distal tip was located around the 7th¿8th rib rather than within the recommended 2nd¿3rd intercostal space.This malposition led to catheter whip and an unstable arterial waveform, resulting in inconsistent physiological input to the pump.Additional contributing factors included ecg artifact and the inability to aspirate the inner lumen, both indicating suboptimal catheter function.Overall, the device operated as designed, and the alarm was triggered due to inadequate signal quality stemming from catheter malposition rather than a pump and/or iab malfunction.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.
Event or Problem Description
The complaint was received through a direct call from the customer to the emergency support program.It was reported that during use, the console screen of the intra-aortic balloon (iab) revealed artifact present in the ecg and it was also reported that iab catheter was unable to aspirate the inner lumen.No harm reported.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6(health effect ¿ clinical code), h11.Corrected field - b5, e1 (occupation), h6 (type of investigation, medical device ¿ problem code).
Event or Problem Description
The complaint was received through a direct call from the customer to the emergency support program.It was reported that during use customer called for support with an unable to update timing alarm on a cardiosave, troubleshooting revealed a console screen of the intra-aortic balloon (iab) revealed artifact present in the ecg, whip present in the arterial waveform and it was also reported that iab catheter was unable to aspirate the inner lumen.No harm reported.

• Brand Name: LINEAR 7.5FR. 34CC 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: 23490501
• Report Number: 2248146-2025-0000707
• Device Sequence Number: 18280745
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000398317(17)270619(11)240619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2026

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: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000398317
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 02/07/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/28/2026; 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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: CARDIOSAVE PUMP.
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 44 KG