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

Model Number	PTS-0607-7F135
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Vascular Dissection (3160); Unspecified Vascular Problem (4441)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient sustained minor vessel damage with the removal of the clot basket, due to the aggressive use of the device, as well as the mechanical and metal nature of the basket.No other patient injuries, serious, or otherwise were reported.The ifu includes the following contraindication."do not deploy in vessels with previously implanted devices." there is also a warning in the ifu that states, "the basket assembly is not intended to be torqued or advanced without the basket delivery catheter.This may cause vessel damage or compromised device functionality.".
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: POUNCE¿ THROMBUS RETRIEVAL SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): SURMODICS, INC; 7905 golden traianle dr; eden prairie, mn 55344
• Manufacturer (Section G): SURMODICS, INC; 7905 golden triangle dr; eden prairie, mn 55344
• Manufacturer Contact: holly ramirez ; 7905 gloden triangle dr; eden prairie, mn 55344
• MDR Report Key: 12972630
• Report Number: 3014687026-2021-00001
• Device Sequence Number: 20041280
• 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): 12/09/2021

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 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: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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