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

Model Number	0684-00-0470-01C
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Ischemia (1942); Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event site name: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
On (b)(6) 2026, the patient suffered an acute myocardial infarction and was in critical condition.As a life-saving measure, an intra-aortic balloon (iab) was inserted.The procedure was technically challenging because ultrasonography revealed severe calcification of the lower-extremity arteries.Under ultrasound guidance, the iab was eventually inserted with considerable difficulty, resulting in stabilization of the patient's hemodynamic status.The patient subsequently underwent successful coronary artery bypass grafting (cabg).On (b)(6) 2026, during attempted removal of the iab, the balloon became entrapped within atherosclerotic plaque and could not be withdrawn through the vascular access route.Vascular surgeons and general surgeons were consulted, and surgical exploration of the abdomen and groin was performed with arteriotomy to facilitate removal of the balloon.Intraoperatively, the abdominal aorta and common iliac arteries were found to be severely calcified, with marked stenosis and near-complete occlusion in some segments.Due to the extensive vascular calcification and unfavorable anatomy, complete retrieval of the device was not possible.Consequently, a small sterile fragment consisting of the balloon tip remained lodged at the aortic bifurcation and the origin of the iliac arteries.The patient's native vessels were already severely calcified and nearly occluded.Postoperatively, there was no evidence of lower-limb necrosis or infection.Cardiac recovery was satisfactory, and the patient's myocardial condition healed successfully.The patient was subsequently transferred to a tertiary referral center for further evaluation and management of lower-limb ischemia.

• Brand Name: SENSATION 7FR. 40CC IAB (CHINA)
• 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: 25729827
• Report Number: 2248146-2026-0001240
• Device Sequence Number: 13400287
• Product Code: DSP
• UDI-Device Identifier: 10607567109374
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 0684-00-0470-01C
• Device Catalogue Number: 0684-00-0470-01C
• Device Lot Number: 3000469258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male