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

Model Number	0684-00-0469-01U
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 id: (b)(4).
Event or Problem Description
It was reported that intra-aortic balloon(iab) would not advance in the sheath.Ruptured wire lumen.
Event or Problem Description
It was reported that intra-aortic balloon(iab) would not advance in the sheath.Ruptured wire lumen.No harm to the patient.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood was observed on the exterior.One kink was observed on the catheter approximately 76.2cm from the iab tip.The one-way valve was also returned.A visual examination did not reveal a breakage in the inner lumen.A laboratory guidewire insertion test was performed with no difficulty or restriction.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 reported failure of ¿difficult/unable to advance iab through guidewire and damaged component (broken lumen)¿ cannot be confirmed by the evaluation.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.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.The reported failure of ¿difficult/unable to advance iab through guidewire and damaged component (broken lumen)¿ cannot be confirmed by the evaluation.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.Complaint record id # (b)(4).

• Brand Name: (SENSATION 7FR. 34CC IAB WITH ACCESSORIES, US ONLY
• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21522411
• Report Number: 2248146-2025-0000104
• Device Sequence Number: 8339390
• Product Code: DSP
• UDI-Device Identifier: 10607567109541
• UDI-Public: (01)10607567109541(10)3000384650(17)270520(11)240520
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/19/2025

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: 0684-00-0469-01U
• Device Catalogue Number: 0684-00-0469-01U
• Device Lot Number: 3000384650
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown