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

Model Number	PTS-0607-7F135
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the pounce arterial device was returned for anlaysis.Analysis confirmed the reported issue.The funnel with the baskets were still on the basket wire.The funnel and basket wire were cut just proximal to the funnel braid bond and funnel shaft.The remaining funnel shaft was still in the funnel catheter.The funnel shaft appeared to have fracture within the device handle.There was clumps of highly organized clot dried within the funnel and attached to the baskets.
Event or Problem Description
The pounce arterial mid-profile (mp) device was used during a peripheral thrombectomy procedure via left femoral artery access to treat thrombus extending from the right proximal superficial femoral artery (sfa) through the distal sfa into the popliteal artery, estimated at approximately 50-60 cm in length.The physician had not previously used the pounce system and had not received formal in-service training prior to this case.During the first thrombectomy pass, resistance was encountered and the funnel catheter and baskets became entrapped within a 7 fr, 55 cm sheath.Attempts were made to withdraw the device and sheath en bloc; however, separation of the funnel catheter shaft in the device handle occurred.The issue was reported to the manufacturer representative after these events had already occurred.Clot overburden was suspected as the physician tried to remove the entire clot with one pass.No further troubleshooting maneuvers such as aspiration, reverse loading, or controlled rotation were attempted prior to escalation.Surgical intervention was required, including a right femoral arterial cutdown for device retrieval.All components were removed, and the procedure was completed using fogarty embolectomy, followed by surgical repair of the right femoral access and percutaneous closure of the left access site.The total procedural delay was approximately 90 minutes.No additional patient complications were reported.

• Brand Name: POUNCE ¿ THROMBECTOMY
• Common Device Name: Peripheral mechanical thrombectomy with aspiration
• Manufacturer (Section D): SURMODICS, INC.; 7905 golden triangle drive sui; eden prairie MN 55344
• Manufacturer (Section G): SURMODICS, INC.; 7905 golden triangle drive sui; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 23438340
• Report Number: 3014687026-2025-00006
• Device Sequence Number: 4759071
• Product Code: QEW
• UDI-Device Identifier: 00812339030784
• UDI-Public: 00812339030784
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K220501
• 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): 10/31/2025

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 Expiration Date: 01/25/2026
• Device Model Number: PTS-0607-7F135
• Device Lot Number: FG240003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 76 KG