MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01
Medical Device Problem Codes	Difficult to Flush (1251); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitations, the following field has been added from section e1: event site name: (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
It was reported by customer that during use, intra-aortic balloon pump (iabp) had clotted inner lumen.There was no patient harm or injury.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9 (device available for eval), e1 (event site state), g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component codes), h11.Corrected fields: e1 (initial reporter), g2.Additional point of contact: (b)(6).Keeping udi # partial as no details available.It was reported through a direct call from the customer to the emergency support program that during use, intra-aortic balloon (iab) had clotted inner lumen.Aluk stated he had been called to the unit to help troubleshoot a maquet balloon catheter in use on a teleflex pump.He denied any alarms present but stated they were unable to flush or aspirate from the inner lumen of the catheter.I advised aluk to cap and label the inner lumen as so to prevent further use.I also recommended he notify the provider of the clotted inner lumen.He said they had already done so and were inquiring about any further troubleshooting.Complaint information obtained.I spoke to the bedside team who agreed to return the catheter after discontinuation.I also recommended calling teleflex for further suggestions for therapy with a clotted inner lumen and they had already done so.They were appreciative of the support and denied any further needs.
Event or Problem Description
It was reported through a direct call from the customer to the emergency support program that during use, intra-aortic balloon (iab) had clotted inner lumen.Aluk was unable to flush or aspirate from the inner lumen of the catheter.There was no patient harm or injury.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• 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: 23816186
• Report Number: 2248146-2025-0000844
• Device Sequence Number: 9387200
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• 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): 01/24/2026

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: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000355209
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: TELEFLEX PUMP.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 63 KG