MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
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 that a linear 34 cc intar-aortic balloon did not open.Pressed iab fill button and balloon still did not inflate.Patient was involved.There were no patient complications.
Event or Problem Description
It was reported that a sensation 7fr.40cc intra-aortic balloon (iab) did not open.Pressed iab fill button and balloon still did not inflate.Patient was involved.There were no patient complications.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood was observed on the iab exterior.One kink was observed on the catheter tubing approximately 76.2cm from the iab tip.The one-way valve was also returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed, and no leaks were detected.One-way valve vacuum test was preformed, and it was able to hold vacuum.The iab was placed on the cardiosave pump and the iab fully inflated.No alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.The evaluation determined a kink in the catheter tubing.It is difficult to determine when or how a kink in the catheter occurs.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.

• Brand Name: SENSATION 7FR. 40CC IAB
• 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: 22174976
• Report Number: 2248146-2025-0000307
• Device Sequence Number: 7957869
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000379317(17)270410(11)240410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2025

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000379317
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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: UNKNOWN.
• Patient Age: 43 YR
• Patient Sex: Female