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

Model Number	0684-00-0469-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 event site name 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 id # (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) iab therapy, balloon had a leak.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person ¿ mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was not a maquet product.Two kinks were found on the catheter tubing approximately 39.1cm and 42.4cm from iab tip.A kink was found on the catheter tubing and inner lumen near y-fitting approximately 76.2cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected on the membrane approximately 1cm from the rear seal measuring 0.013cm in length.The optical fiber was also found to broken at this location.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record id no.(b)(4).
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 34CC 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21177212
• Report Number: 2248146-2025-0000031
• Device Sequence Number: 15587925
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000351710(17)261117(11)231117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• 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): 02/21/2025

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: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000351710
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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: 82 YR
• Patient Sex: Female