MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB (WITH STATLOCK); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-01
Medical Device Problem Code	Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional initial reporter: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use of balloon catheter intra-aortic balloon (iab) the intra-aortic balloon pump (iabp) displayed an appropriate waveform, but the pressure readings were abnormally low and inconsistent with the patient¿s clinical presentation and noninvasive blood pressure measurements.Despite no signs of a damped waveform, the pressures improved temporarily with site manipulation, suggesting possible catheter positioning issues or signal interference.After troubleshooting including flushing, electrode replacement, and restarting therapy the readings slightly improved but remained significantly lower than expected, prompting plans for catheter removal.
Additional Manufacturer Narrative
Updated fields: b4, e1 (event site state), g3, g6, h2, h11.Corrected fields: d9 (device available for eval, return to manufacture date), d10, e1 (initial reporter), h3, h6 (type of investigation).
Event or Problem Description
It was reported that during use of balloon catheter intra-aortic balloon (iab) the intra-aortic balloon pump (iabp) displayed an appropriate waveform, but the pressure readings were abnormally low and inconsistent with the patient¿s clinical presentation and noninvasive blood pressure measurements.Despite no signs of a damped waveform, the pressures improved temporarily with site manipulation, suggesting possible catheter positioning issues or signal interference.After troubleshooting including flushing, electrode replacement, and restarting therapy the readings slightly improved but remained significantly lower than expected, prompting plans for catheter removal.No harm reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected field: b5.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was not a maquet product.The pressure tubing was also returned.No kinks were detected on the returned iab catheter.The technician was able to successfully aspirate the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported event cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The device meets all product specifications.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.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK)
• 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: 23434562
• Report Number: 2248146-2025-0000677
• Device Sequence Number: 12895087
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 3000453789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 12/12/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/04/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 & CATHETER.
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 66 KG