MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION QUICKCLEAR THROMBECTOMY SYSTEM; ASPIRATION THROMBECTOMY CATHETER

Model Number	AC10SH085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a quick clear device was used in a clinical study to treat an occlusive deep vein thrombosis (dvt) on the external iliac vein, common femoral vein, femoral vein, and nonocclusive dvt located above the knee in the popliteal.However, 2 days post index procedure on (b)(6) 2025, the patient experienced left inner thigh redness and pain with extreme pressure while walking.Four days later on (b)(6) 2025, a follow up call revealed that the patient was admitted to the hospital and started heparin drip with no other intervention performed.It was indicated that this is possibly related to study device and possibly related to the study procedure.This adverse event is being submitted because the patient experienced redness and pain on the left leg, resulting in hospitalization and intervention.
Additional Manufacturer Narrative
Block a3b: the patient's gender is unknown.This information was not available from the facility.Block h3: the quickclear device was discarded by the facility, thus no returned product investigation was performed.Block h6: per the ifu, access site injury, including pain is listed as a possible adverse event.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: QUICKCLEAR THROMBECTOMY SYSTEM
• Common Device Name: ASPIRATION THROMBECTOMY CATHETER
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• Manufacturer Contact: diana melliza galvez ; 5905 nathan lane north; plymouth, MN 55442
• MDR Report Key: 24654553
• Report Number: 3016257349-2026-00009
• Device Sequence Number: 14979875
• Product Code: QEZ
• UDI-Device Identifier: 00845225003142
• UDI-Public: (01)00845225003142(17)250620(10)302931352
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2025
• Device Model Number: AC10SH085
• Device Catalogue Number: AC10SH085
• Device Lot Number: 302931352
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS: 10 F BRITE TIP INTRODUCER SHEATH; PHILIPS: QUICK-CROSS SELECT SUPPORT CATHETER; TERUMO: 0.035" GLIDEWIRE GUIDEWIRE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White