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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported through a direct call from the customer to the emergency support program that during use, the intra-aortic balloon (iab) had a leak and needed clarification on clamping the tubing after a balloon leak.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (event site name: (b)(6)).A supplemental report will be submitted upon completion of our investigation.Complaint id# (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (type of investigation).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h11.Corrected field: d7a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b1, b4, d9, g3, g6, h2, h3, 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.A customer complaint was received via a direct call to the emergency support program regarding clarification on clamping helium tubing after a balloon leak.The rn reported that after observing blood in the helium tubing, he stopped the pump and clamped the tubing, but later received conflicting instructions from the cardiologist.The nurse requested clarification and documentation to update hospital policy.Correct steps were reviewed: place the pump in standby, disconnect the extender tubing, and then clamp the extracorporeal helium tubing.Supporting resources were provided via email and show pad, and arrangements were made to return the catheter for product surveillance.No patient harm or injury was reported.Based on the description, the balloon had a leak in the helium tubing, however it is impossible to define how the failure may have occurred since the product was not returned for evaluation.The device was requested to sent for evaluation ad a catheter kit was sent to the customer.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.

• 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: 23360808
• Report Number: 2248146-2025-0000646
• Device Sequence Number: 9201940
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000453789(17)280217(11)250217
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/22/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 12/17/2025; 12/22/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 10/23/2025; 12/18/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 87 KG