MAUDE Adverse Event Report: SURMODICS, INC. POUNCE SHEATH; PFS-0035-12F14

Model Number	PFS-0035-12F14
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pounce sheath was used in a left and right iliac vein and inferior vena cava (ivc) thrombectomy procedure.The sheath was used in conjunction with the 12fr aspiration catheter.The physician encountered resistance and noted the tip of the catheter became damaged during the process.There was no reported patient harm or procedure delay.The pounce sheath was inserted at an approximate 45 degree angle.The reported issue occurred during the initial insertion of the aspiration catheter.The pounce sheath was not used for more than one access site.The reported issue did not result in negative consequences.The sheath was exchanged for a regular 12f sheath and the procedure was completed without issue.There was a procedure delay of approximately five minutes.A provided photo showed inner shaft braid wire around the aspiration catheter.
Additional Manufacturer Narrative
H3: the pounce sheath was returned for analysis.Analysis confirmed the reported issue.Destructive analysis found a severe kink at the strain relief of the outer shaft.The inner shaft had a severe fracture as the same location as the outer shaft.Sectioning of the inner shaft found missing braid wire near the kink and moved approximately 2 inches distally.

• Brand Name: POUNCE SHEATH
• Common Device Name: PFS-0035-12F14
• 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: 22367862
• Report Number: 3014687026-2025-00002
• Device Sequence Number: 7971849
• Product Code: DYB
• UDI-Device Identifier: 00812339030753
• UDI-Public: 00812339030753
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K231828
• 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): 06/30/2025

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 Expiration Date: 09/23/2026
• Device Model Number: PFS-0035-12F14
• Device Lot Number: 107888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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
• Patient Sex: Female