MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01U
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Nausea (1970); Implant Pain (4561)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient in the icu with an intra-aortic balloon (iab) was found to have rust-colored discoloration in the helium line during a routine check at 1000, though it had been clear at 0900.The pump did not alarm, and the patient remained stable.Cardiology fellow dr.Chen attempted to remove the balloon from the right femoral artery but encountered resistance.The sheath was removed, but the balloon remained in place.Attending dr.Klein was notified, and the patient, experiencing pain and nausea, was given hydromorphone and ondansetron.Dr.Cole from critical care assisted, and dr.Mason replaced the sheath, initiating iv antibiotics.After a ct scan, the patient was started on heparin and antibiotics (vancomycin and zosyn) before being transferred to the uw b4/5 unit at 1445.Surgical intervention was planned for balloon removal and potential femoral artery repair in the or.
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).
Additional Manufacturer Narrative
No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.The failure mode is addressed in all iab risk files.All iab ifus address 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.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.Based on the rational provided above, no escalation to the capa process is required.Complaint record id # (b)(4).
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 7.5FR. 40CC 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: 21501533
• Report Number: 2248146-2025-0000098
• Device Sequence Number: 7962508
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• 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): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 61 KG