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	Inappropriate Waveform (2536); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields b4 g3 g6 h2 h6 type of investigation investigation findings investigation conclusions h11 no decon or visual inspection performed since product was not returned and could not be evaluated the complaint involved a direct call from the customer to the emergency support program with no reported harm or injury to the patient lauren an icu rn reached out after an auto r wave deflate message appeared when the patient converted from sinus rhythm to atrial fibrillation review of the provided screenshots showed ecg artifact with pacer spikes an arterial waveform with pressures of 34 22 and a map of 42 augmentation at 69 and an informational message indicating the system was unable to update timing after lauren aspirated and flushed the system in standby for 20 seconds the timing issue resolved although arterial pressures improved only to 49 33 with a map of 51 she was advised to replace the ecg electrodes apply doppler gel to improve conduction and reposition electrodes so they hugged the heart a review of the patients chest x ray from january 23 2026 showed the distal balloon marker between the 4th and 5th intercostal space and she was advised to obtain a new x ray and consult the physician regarding placement the updated x ray revealed the distal marker in the 5th intercostal space and the recommendation to consult the physician was repeated lauren expressed appreciation for the support and had no further questions notification was sent to jason stotts chase lilly and keneen childress since the product was not returned we were unable to perform a device evaluation based on the event description the balloons distal position contributed to the reported problem 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 nonconforming 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
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 through emergency support program that the linear 34cc had an auto r wave deflate message related issue.Nurse called requesting information for an auto r wave deflate message that appeared after the patient¿s heart rate went from sinus rhythm to atrial fibrillation.Esp personal reviewed the nature of the message with nurse.Esp personal also reviewed a screenshot of the iabp monitor which revealed an ecg with artifact and pacer spikes, an arterial waveform using transducer as well as an unable to update timing informational message.Nurse aspirated successfully and flushed in standby for 20 seconds.This resolved the unable to update timing alarm.Esp personal also recommended replacing the ecg electrodes, placing doppler gel on the back of each one and placing the ecg electrodes as if they were hugging the heart to increase conduction.Esp personal reviewed a screenshot of the previous chest xray taken and the distal marker appeared to be in between the 4th and 5th intercostal space.Esp personal recommended obtaining a new chest xray and consulting the physician to discuss placement.Nurse sent a screenshot of the new chest xray which revealed the distal marker was in the 5th intercostal space.Esp personal recommended consulting the physician to discuss placement.No patient harm or injury 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: 24341421
• Report Number: 2248146-2026-0000692
• Device Sequence Number: 9962829
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000448002(17)280124(11)250124
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 3000448002
• 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: 01/25/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 68 KG