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

Model Number	0684-00-0296-02
Medical Device Problem Codes	Restricted Flow rate (1248); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that during use the mega 50cc (iab) alarmed due to catheter restriction.No harm or injury reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (medical device problem code, type of investigation, investigation findings and investigation conclusions), h11.Corrected field: d7a.Revert a1 section to blank.No decon or visual inspection performed since product was not returned and could not be evaluated.Calvin, a sicu rn, contacted the clinical support line regarding an iab catheter restriction alarm.The issue had persisted for 8¿10 minutes despite initial troubleshooting efforts, including pressing "start" multiple times.Therapy resumed briefly but the alarm continued.Visual inspection showed no blood or damage in the helium tubing, and connections were secure.A screenshot of the iabp monitor suggested a possible kink due to flattened balloon waveform peaks.A chest x-ray was obtained but the distal marker was not visible.A second x-ray was recommended to confirm proper positioning.Further inspection revealed a non-getinge sheath at the femoral insertion site that appeared kinked.Nursing interventions such as repositioning and dressing replacement were advised.Calvin shared these recommendations with the physician, who was actively forming a plan with an interventionalist.Later, calvin confirmed that repositioning the balloon catheter resolved the alarm.Based on the description, the kink at the femoral insertion site due to a non-getinge sheath, leading to restricted balloon inflation and triggering the iab catheter restriction alarm.The issue was resolved by repositioning the catheter, confirming that the kink was the primary cause.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
N/a.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK & APA)
• 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: 23093597
• Report Number: 2248146-2025-0000562
• Device Sequence Number: 15871168
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: (01)10607567108018(10)3000452583(17)280210(11)250210
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 10/23/2025

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: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0296-02
• Device Lot Number: 3000452583
• 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: 08/31/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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: UNKNOWN.
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 54 KG