MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: e1, occupation, h6 component codes inadvertently added.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy while attempting to insert the intra-aortic balloon using the introducer, blood was observed.Upon connecting the device to the counterpulsation console, it indicated 'balloon rupture' for both balloons used.".
Additional Manufacturer Narrative
Due to character restrictions in block e1 (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).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component code), h11 corrected fields: h6 health effect ¿ clinical code, impact codes.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 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.Complaint record id 1300167.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5, b6, b7, b8, d10, h6 (health effect ¿ impact codes).
Event or Problem Description
It was reported during the very initial phase of catheter insertion that blood was observed in intra-aortic balloon (iab).Upon connecting the device to the counterpulsation console, it indicated balloon rupture.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d9 (device available for eval?, return to manufacture date), e1 (event site email), g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Event site state: (b)(6).The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The one-way valve was also returned separate from the iab.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected on the membrane approximately 2.5cm from the iab tip measuring 1.3cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.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 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: SENSATION 7FR. 34CC 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: 22193337
• Report Number: 2248146-2025-0000314
• Device Sequence Number: 8562134
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000384650(17)270520(11)240520
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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,Followup
• Report Date (Section B): 01/19/2026

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: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000384650
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/09/2025; 01/12/2026; 01/19/2026
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/03/2025; 07/08/2025; 01/16/2026; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown