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 Codes	Break (1069); Pacing Problem (1439); Failure to Sense (1559); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 the full initial reporter's name is dr (b)(6).(b)(6).The fll event site address is (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 (b)(4).
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy, the balloon device could not be operated via the artery since the pressure sensor was not detected.It was reported that they did not see any harm or injury.
Additional Manufacturer Narrative
Updated fields: b4, d9(device available for eval, return to manufacture date), d10, g1(contact person ¿ mfg site), g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: e1(event site name, event site address), e3.Due to character restrictions in block e1.Event site name: (b)(6) hospital.Event site address: (b)(6).The iab was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned.The inner lumen found occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and no breaks were observed along the length of the optical fiber.Additionally, the iab was sent for root cause investigation by the supplier and there investigation revealed that the optical fiber was broken inside the connector assembly.The evaluation confirmed the reported failure.The lot of this sensor cable assembly was identified that this product was manufactured prior to the corrective actions documented in 21-f-scar-14 and has implemented actions to address the root cause of optical fiber breakages inside the connector assembly for the failure reported complaints.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.Complaint id# (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: if implanted, give date: not applicable.
Additional Manufacturer Narrative
Updated fields: b4, d8, g3, g6, h2, h11.Corrected field: h6 (medical device problem code).
Event or Problem Description
N/a.

• 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: 22305668
• Report Number: 2248146-2025-0000325
• Device Sequence Number: 8081725
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000367226(17)270222(11)240222
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (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
• Report Date (Section B): 10/27/2025

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: 3000367226
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 10/23/2025; 10/27/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 10/20/2025; 10/24/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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.; UNKNOWN.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG