Pounce™ Thrombectomy System PTS-0607-7F135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812339030296), received between Dec 9, 2021 and Jun 5, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2023Fracture; Fracture

  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 PERFORM

  Patient problems: Foreign Body In Patient

  MAUDE report 17063712 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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

  Patient problems: Vascular Dissection

  MAUDE report 16873286 ↗
• MalfunctionFeb 9, 2022Off-Label Use; Detachment of Device or Device Component; Device Damaged by Another Device; Off-Label Use; Detachment of Device or Device Component; Device Damaged by Another Device

  FOLLOW-UP REPORT TO SUBMIT ADDITIONAL INFORMATION NOT KNOWN AT TIME OF INITIAL SUBMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501482 ↗
• MalfunctionDec 9, 2021Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  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."

  Patient problems: Unspecified Vascular Problem; Vascular Dissection

  MAUDE report 12972630 ↗