MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (TURKEY); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-09
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 type of investigation, investigation findings, investigation conclusions, h11.Corrected field h6 medical device problem code.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 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, d9 date received to manufacture, g3, g6, h2, h11 corrected field is d9,h3, h4, h6 type of investigation investigation, findings, investigation conclusions 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 half of the balloon a second sheath was returned separate from the iab and it was not a maquet product additionally the one way valve and two dilators were also returned two kinks were observed on the inner lumen within the membrane approximately 135cm and 15cm from iab tip a kink was found on the catheter tubing approximately 709cm from iab tip a laboratory insertion test was unable to be performed due to the inner lumen kinked the sheath was measured and found dimensionally within specification the condition of the iab as received indicated kinks on the inner lumen and catheter tubing a kink in the inner lumen can cause difficulty during insertion we are unable to determine when the kinks may have occurred the evaluation confirmed the reported problem 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 rationale provided above no escalation to the capa process is required.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6) hospital, event site address: (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 that after the interventional set platformers come out of the balloon, the balloon itself doesn't pass through the 8f fit that put in the patient with formalin, and also removed the air with syringes, but then also it goes into the sit, but not the tip.There was no patient harm or injury reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d10.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d4 (exp date and udi), e1 (initial reporter and event site address), h4, h6 (medical device problem code).
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (TURKEY)
• 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: 24220209
• Report Number: 2248146-2026-0000640
• Device Sequence Number: 8392638
• Product Code: DSP
• UDI-Device Identifier: 10607567113173
• UDI-Public: (01)10607567113173(10)3000459653(17)280307(11)250307
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 0684-00-0576-09
• Device Catalogue Number: 0684-00-0576-09
• Device Lot Number: 3000459653
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 04/07/2026; 04/29/2026; 04/29/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/09/2026; 04/08/2026; 04/29/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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: IABP.; UNKNOWN.
• Patient Sex: Unknown