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

Model Number	PTS-0607-7F135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The arterial thrombectomy device was being used in a superficial femoral artery (sfa) procedure.The surgeon made two passes with a competitor guidewire in order to cross the lesion with minimal resistance.The device was deployed in the proximal sfa and the device funnel had a "funny twisted" shape on imaging.It was thought the funnel was deployed in to the lesion or chronic material.The funnel was re-sheathed and pulled back and redeployed.The funnel then deployed to the expected shape.Upon device removal after the initial pass, some chronic material was in the basket and funnel.The device was removed with minimal resistance.Once out, the tip of the basketwire was entangled with the funnel, which was able to be easily freed by pulling the basketwire further into the funnel so the basketwire tip cleared the tip of the funnel.An angiogram was taken and the vessel "looked worse" than the previous image taken prior to guidewire crossing.The surgeon believed the vessel was dissected and they were unable to cross the lesion into the true lumen space from this access point.The surgeon then obtained pedal access into what was thought to be the true lumen space.The guidewire was then externalized through the initial access point guide sheath so a balloon could then be placed.Two stents were then emplaced.The procedure was considered successful and arterial flow was restored.The patient did not experience any further impact.There was no procedure delay.

• 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 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 ; 9525007000
• MDR Report Key: 16873286
• Report Number: 3014687026-2023-00004
• Device Sequence Number: 7261992
• Product Code: QEW
• UDI-Device Identifier: 00812339030296
• UDI-Public: 00812339030296
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 05/04/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: PTS-0607-7F135
• Device Lot Number: FG220021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 79 KG