MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Difficult to Flush (1251); Difficult to Insert (1316); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
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 id# (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, insertion of the 0.018 guide inside the balloon felt more difficulty than usual, once the guide has been removed the customer prepared to aspirate but it failed.New balloon has been replaced continue the therapy but a bit of difficulty in aspirating and infusing is still recorded to.No harm to the patient linked to the balloon.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected field: h6 (type of investigation).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (health effect ¿ clinical code), h11.Corrected field - d10.
Additional Manufacturer Narrative
Correct field d4 lot and udi number.Updated field b4, d4 expiry date, d9, g3, g6, h2, h3, h4, h6 type of investigation findings.Investigation conclusions, h11.A 40cc balloon was inserted under angiographic guidance and difficulty was immediately noted when advancing the 0018 guidewire through the balloon.After the guidewire was removed the clinician attempted to aspirate and flush the balloon but no fluid returned through the wash line aspiration was very difficult and infusion nearly impossible.After consulting with the physician the team reinserted the guidewire with difficulty but the lumen remained nonpatent once the guidewire was removed again.The decision was made to replace the balloon.The second balloon allowed smooth guidewire advancement and proper positioning though some resistance during aspiration and infusion persisted nevertheless therapy proceeded successfully.The balloon functioned adequately throughout treatment and was later removed after bypass surgery with the patient continuing on impella support.No patient harm was associated with the balloon issue.Postprocedure testing of the first balloon showed that flushing was possible but aspiration was still blocked.Both balloons were ultimately discarded.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore we were unable to confirm or determine a root cause for the reported failure.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: SENSATION 7FR. 40CC 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: 23644219
• Report Number: 2248146-2025-0000773
• Device Sequence Number: 9764678
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000450286(17)280205(11)250205
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063525
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000450286
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 01/31/2026; 02/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/30/2026; 02/02/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: IMPELLA.; UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG