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 Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
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 record id (b)(4).
Event or Problem Description
It was reported by the customer via emergency support line that the intra-aortic balloon (iab) experienced a catheter restriction alarm during use.There was no patient harm reported.
Additional Manufacturer Narrative
Updated fields - b4, d9 date return to manufacture, g3, g6, h2, h6 type of investigation, investigation findings, investigation conclusions, h11 corrected field d9 device available for evaluation, h3, h5 a cvicu nurse, (b)(6), requested help with a catheter restriction alarm on a cardiosave.No patient harm occurred.She confirmed proper connections and no blood in the helium line.An autofill was attempted but didn¿t clear the alarm.While discussing further troubleshooting, the attending decided to remove the balloon catheter and stop therapy.Kristy expressed appreciation for the support.A follow up at 3:00 pm confirmed the patient was stable without therapy.The product was returned with the membrane completely unfolded.Blood on the exterior of the iab.The sheath was covering the extender tubing.The extender tubing was also returned for evaluation.Four catheter tubing kink were observed approximately 76.4cm, 75.4cm, 74.4cm and 73.1cm from the iab tip.An underwater leak test of the balloon, catheter, y fitting, extracorporeal tubing and extender tubing was performed, and no leaks were detected.The iab was placed on the cardiosave pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally, and no alarm sounded from the pump.The reported event of alarm, catheter restriction cannot be confirmed by the evaluation.Four kinks were observed on the catheter tubing, which may lead to a catheter restriction.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 months.Based on the rational provided above, no escalation to the capa process is required.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field - h6 (investigation findings).
Event or Problem Description
N/a.

• 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: 24144111
• Report Number: 2248146-2026-0000478
• Device Sequence Number: 21054530
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000342806(17)261013(11)231013
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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: 3000342806
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 03/10/2026; 03/12/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/11/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 71 KG