MAUDE Adverse Event Report: SURMODICS, INC. POUNCE ¿ XL THROMBECTOMY; Peripheral mechanical thrombectomy with aspiration

Model Number	PTS-1011-7F135
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient presented with no flow through a 6mm graft from the right common femoral artery (rcfa) to the posterior tibial artery (pt).Left common femoral access was obtained using a 7f sheath, later exchanged for an 8f sheath to accommodate multiple thrombectomy passes.Two successful passes were completed using the pounce xl in chronic right-sided vessels and the occluded bypass segment.During a third pass through the native rcfa, a substantial quantity of organized thrombus was captured in the device funnel and baskets.Upon attempting to remove the loaded system through the 8f sheath, resistance was encountered.This was presumed to be due to the thrombus volume burdening the lumen clearance of the sheath.Additional traction was applied, which resulted in the inner lining of the sheath being pulled inward and/or stripped.This led to the alleged detachment of the funnel and baskets from the pounce system.Device components (still engaged with thrombus) became entrapped within the vasculature.During a follow-up phone call, the manufacturer representative could not confirm if the device baskets had separated from the basket wire.A surgical cutdown of the left common femoral artery was required to retrieve the 8f sheath, device funnel, baskets, and clot material as one unit.The procedure was ultimately successful, with bounding distal pulses noted.No retained device fragments or patient harm was reported.The device was discarded post-procedure and is not available for evaluation.
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.

• Brand Name: POUNCE ¿ XL THROMBECTOMY
• Common Device Name: Peripheral mechanical thrombectomy with aspiration
• Manufacturer (Section D): SURMODICS, INC.; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer (Section G): SURMODICS, INC.; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 22476060
• Report Number: 3014687026-2025-00003
• Device Sequence Number: 8677700
• Product Code: QEW
• UDI-Device Identifier: 00812339030807
• UDI-Public: 00812339030807
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K241362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: PTS-1011-7F135
• Device Lot Number: FG250027
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female