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

Model Number	PTS-0607-7F135
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the device was returned for analysis.The funnel and inner catheter shaft were separated from the delivery catheter.The funnel separated at the inner shaft bond.The damage sustained was consistent with the report forcing the device through the procedural sheath.
Event or Problem Description
The device was used in a thrombectomy procedure to remove superficial femoral artery (sfa) thrombus.The device made a successful initial pass without incident.During the second pass, the funnel would not pass through the tip of the 7fr sheath.Multiple attempts were made to remove the funnel through the sheath.During the final attempt to forcibly remove the device, the funnel became detached from inner white catheter.A surgical vessel cutdown was then performed to successfully remove the detached funnel and the white inner catheter.The procedure was completed without further patient impact.The reported issue resulted in a procedure delay of four hours.

• Brand Name: POUNCE ¿ 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: 20617189
• Report Number: 3014687026-2024-00003
• Device Sequence Number: 20721166
• Product Code: QEW
• UDI-Device Identifier: 00812339030784
• UDI-Public: 00812339030784
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/07/2024

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: 10/06/2025
• Device Model Number: PTS-0607-7F135
• Device Lot Number: FG230035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2024
• 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 Sex: Unknown