MAUDE Adverse Event Report: Datascope Corp. SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet); System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0576-01
Medical Device Problem Codes	Device Sensing Problem (2917); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6(medical device problem code, type of investigation, investigation findings, component codes, investigation conclusions), h11.Correction field: d1, d4, d10, h3.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.The sensor cable, pressure and extracorporeal tubing were returned cut in two parts.A kink was observed on the catheter tubing approximately 39.6cm from iab tip.Upon receipt, the sensor cable was found cut into two separate parts.As a result, we were unable to perform the required sensor test.We were unable to conclusively determine if there was a problem with the ability to monitor the pressure waveform due to the returned condition of the iab as we were unable to fully evaluate the iab.The reported event cannot be confirmed by the evaluation.
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)
• 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: 50493646
• Report Number: 2248146-2026-0001464
• Device Sequence Number: 10224291
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: (01)10607567109633(10)3000525520(17)290202(11)260202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000525520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2026
• 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: Intra-Aortic Balloon Pump (IABP)
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 215 LB