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	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1: event site name:(b)(6).Event site state: (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 the customer on that they received a sensation plus 40cc intra-aortic balloon(iab) kit with 2 balloon trays and no insertion tray.There was no patient involved.
Additional Manufacturer Narrative
Updated fields b4 d9 g3 g6 h2 h3 h6 type of investigation findings investigation conclusions h11.No decon or visual inspection performed since product was not returned and could not be evaluated a photo showing two iab kits and no insertion kit was provided a review of our device history record identified both the iab kit and insertion kit was packaged prior to leaving the manufacturing facility the root cause of missing insertion kit cannot be determined as it occurred after shipment of the device and was out of getinges control 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 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 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: 24158590
• Report Number: 2249723-2026-0000794
• Device Sequence Number: 15731175
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000301652(17)260305(11)230306
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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 Expiration Date: 03/05/2026
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000301652
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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: N/A.
• Patient Sex: Unknown