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

Model Number	0684-00-0608
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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 that during use, trans-ray plus 7.5fr 40cc iab catheter inspection alarm was triggered two days after insertion.The catheter was removed without replacement at the end of treatment.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields b4 g3 g6 h2 h6 (type of investigation, investigation findings, conclusion) h11 corrected field 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 a kink was observed on the sheath tubing approximately 3cm from sheath tip the returned sheath was not a maquet product the extender and pressure tubing were also returned two kinks were found on the catheter tubing and inner lumen approximately 422cm and 455cm from iab tip a third kink was found on the catheter tubing approximately 732cm from iab tip an underwater leak test of the balloon catheter yfitting extracorporeal extender and pressure 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 evaluation determined kinks in the catheter tubing and inner lumen it is difficult to determine when or how kinks in the catheter occurs although we did not repeat this event in the laboratory setting a kink in the catheter can cause inflation difficulty or an alarm the reported event cannot be confirmed by the evaluation 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.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d10 and h6 (type of investigation).
Event or Problem Description
N/a.

• Brand Name: TRANS-RAY PLUS 7.5FR 40CC IAB WITH 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: 24408653
• Report Number: 2248146-2026-0000713
• Device Sequence Number: 8299917
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)271014(10)3000425582(11)241014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000425582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 03/31/2026
• Initial Report FDA Received Date: 02/21/2026
• Supplement Report FDA Received Date: 03/17/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: PUMP
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 65 KG