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

Model Number	PTS-0607-7F135
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event was described as the basket partially breaking when being pulled back through a stented lesion.The basket caught on part of the stent and force had to be used to dislodge the basket from the stent.Any breaking of the basket could lead to sharp edges on the basket which may lead to vessel damage or perforation.This procedure was performed off-label as the ifu for pounce has a specific warning not to use the device in vessels that have been stented.The device was also used for 6 passes, over the limit of 3 allowed by the ifu.No patient harm.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: POUNCE¿ THROMBECTOMY SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): SURMODICS, INC; 7905 golden triangle dr; eden prairie, mn 55344
• Manufacturer (Section G): SURMODICS, INC; 7905 goldentriangle dr; eden prairie, mn 55344
• Manufacturer Contact: holly ramirez ; 7905 golden triangle dr; eden prairie, mn 55344
• MDR Report Key: 13501482
• Report Number: 3014687026-2022-00001
• Device Sequence Number: 4886497
• Product Code: QEW
• UDI-Device Identifier: 00812339030296
• UDI-Public: 00812339030296
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PTS-0607-7F135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown