MAUDE Adverse Event Report: SURMODICS INC POUNCE¿ THROMBECTOMY SYSTEM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	PTS-0607-7F135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The device was being used during a thrombectomy procedure with popliteal artery access.The device was used for a pass in the iliac artery with great results.A second pass was performed in the mid posterior tibial artery.Prior to withdrawal, both baskets were visualized in the funnel via fluoroscopy.When the funnel catheter and basket wire were removed and exposed, only one of the two baskets remained (distal basket separation).The device funnel was flushed and the second basket was missing.Imaging was performed and the basket remained in the patient, mid-posterior tibial.The basket had migrated back down because both baskets were in the funnel in the distal superficial femoral artery (sfa)/popliteal artery before removal.The physician was unable to aspirate or snare the basket out and it remained in the patient.Because there was no distal flow in the popliteal artery, the physician chose to leave.No resistance was experienced during device insertion or removal.The target lesion had no calcification and the device as not placed through any stents.A high amount of organized thrombus was removed; ranging from subacute to chronic.An additional cutdown procedure was performed the next day to remove the basket.There was no reported procedure delay.There was no further impact to the patient.
Additional Manufacturer Narrative
H3: device analysis of the basket wire confirmed the reported issue.The basket wire, delivery catheter, and funnel catheter were received for analysis.The distal basket was not present on the basket wire and was discarded by the site.Inspection of the distal basket collar and weld found the three struts had fractured at the collar.The reported failure mode was consistent with a known device issue.

• Brand Name: POUNCE¿ THROMBECTOMY SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie
• 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 ; 9525007000
• MDR Report Key: 17063712
• Report Number: 3014687026-2023-00005
• Device Sequence Number: 15163964
• Product Code: QEW
• UDI-Device Identifier: 00812339030296
• UDI-Public: 00812339030296
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 08/17/2023
• Device Model Number: PTS-0607-7F135
• Device Lot Number: FG220021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 136 KG