MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB (INDIA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-07
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 event site name: (b)(6).The product has been returned to the manufacturer but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted complaint record id (b)(4).
Event or Problem Description
It was reported by the customer through emergency support program that the sensation 34cc had fiber optic sensor failure alarm on a cs300 during use.Nurse stated that the attending had advanced the catheter at the bedside and following the repositioning, the alarm was present.She denied any kink or fold in the fo cable and stated that she had already unplugged and re plugged the fo sensor cable once before.Esp personal asked her to repeat the step, verifying that it was arrow to arrow and seated appropriately.Esp personal then reviewed the steps to transition from fo to transducer as the pressure source and requested she coil, tape and label the fo cable as fiber optic sensor failure.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6, type of investigation, investigation findings, investigation conclusions h11.A ccu nurse (b)(6) called for help regarding a fiber optic sensor failure alarm on a cs300 during patient use no patient harm occurred she reported that the alarm began after the attending physician advanced the catheter at the bedside (b)(6) confirmed there were no kinks or folds in the fiber optic cable and had already tried unplugging and reconnecting the sensor once she was instructed to repeat the reconnection step ensuring proper alignment and was then guided on how to switch the pressure source from fiber optic to transducer she was also asked to coil tape and label the fiber optic cable as fiber optic sensor failure do not use complaint details were collected and (b)(6) expressed appreciation reporting no further needs.The product was returned with the membrane completely unfolded and blood found on the exterior between iab and sheath and traces inside the inner lumen the maquet sheath was returned covering the membrane of the iab the device was returned cut and the extracorporeal tubing and sensor cable were not returned for evaluation a fiber optic break was found approximately 221cm from the iab tip.The reported failure was confirmed by a evaluation a fiber optic break was found within the membrane 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 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 field - h6 (investigation findings).
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 34CC IAB (INDIA)
• 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: 24322549
• Report Number: 2248146-2026-0000688
• Device Sequence Number: 18600968
• Product Code: DSP
• UDI-Device Identifier: 10607567109732
• UDI-Public: (01)10607567109732(10)3000467436(17)280416(11)250416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• 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): 03/19/2026

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: 0684-00-0469-07
• Device Catalogue Number: 0684-00-0469-07
• Device Lot Number: 3000467436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 03/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/12/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: CS300.
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 56 KG