MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5FR. 40CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0295-02
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Smoothly insert the iab catheter.Normal pumping about 55h, alarmed" leak in iab circuit" and found blood in the tubing.Then pull out the iab catheter.
Additional Manufacturer Narrative
Due to characterization limit e1 event site telephone: (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 record id (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5, d1 (brand name), d4 (version or model #, catalog #, unique identifier (udi) #), h6 (medical device problem code).Event site telephone: (b)(6).
Event or Problem Description
It was reported that intra aortic balloon (iab) was smoothly inserted and alarm triggered leak in iab circuit.Blood was found in the tubing.Catheter was pull out.There was no patient harm reported.
Additional Manufacturer Narrative
Due to characterization limit e1 event site name: (b)(6).Updated fields b4 d9 g3 g6 h2 h3 h6 type of investigation findings conclusion h11.The iab was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter the extracorporeal tubing was removed from the iab and not returned a visual examination of the product detected the inner lumen within the catheter tubing was completely separated within a kink approximately 765 cm from iab tip an underwater leak test of the balloon catheter and yfitting was performed and no other leaks were detected.The evaluation determined an inner lumen break within a catheter kink causing the reported problems it is difficult to determine when or how this occurred the evaluation confirmed the reported problems 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 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.
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5FR. 40CC IAB (WITH 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: 24197441
• Report Number: 2248146-2026-0000590
• Device Sequence Number: 9980006
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: (01)10607567107981(10)3000485195(17)280623(11)250623
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0295-02
• Device Lot Number: 3000485195
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 03/23/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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: CARDIOSAVE.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 50 KG