Pantheris SV A140-SVRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851354004417), received between Aug 7, 2019 and Jun 17, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 2 PASSES THE GUIDEWIRE BECAME TANGLED IN THE DEVICE. WHEN AN ATTEMPT WAS MADE TO REMOVE THE DEVICE IT BECAME TANGLED IN THE SHEATH. A RETROGRADE ACCESS WAS OBTAINED IN THE PTA AND A WIRE WAS ADVANCED ACROSS THE ANTEGRADE PROXIMAL SFA ACCESS SITE TO CONTROL THE SITE BUT THE COVERED STENT INTENDED BE DEPLOYED THERE COULD NOT BE ADVANCED PAST THE AREA DUE TO OBSTRUCTION. A RETROGRADE CONTRALATERAL ACCESS WAS OBTAINED AND A SHEATH WAS PLACED UP AND OVER THE ILIAC BIFURCATION TO CONTROL FROM ABOVE. SHEATH WIRES AND DEVICE WERE REMOVED WITH DIFFICULTY FROM INITIAL ACCESS SITE AND A COVERED STENT WAS PLACED. PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED THE NEXT DAY WITHOUT ANY TREATMENT ADMINISTERED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12019686 ↗
• MalfunctionOct 21, 2020Failure to Unfold or Unwrap; Material Twisted/Bent; Material Split, Cut or Torn; Failure to Unfold or Unwrap; Material Twisted/Bent; Material Split, Cut or Torn

  THE PANTHERIS SV CATHETER WAS ADVANCED TO THE ANTERIOR TIBIAL ARTERY AND ATHERECTOMY PERFORMED WITH NO ISSUES. THE PANTHERIS CATHETER WAS REMOVED AT THE END OF THE PROCEDURE (THE GUIDEWIRE LUMEN WAS FOUND TORN/DETACHED FROM THE NOSECONE). AS THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE, WHICH IS NOT A PRODUCT MANUFACTURED OR DISTRIBUTED BY AVINGER, INC., HE MET RESISTANCE. USING FLUOROCOPY, IT WAS NOTED THAT THE GUIDEWIRE WAS PROLAPSED ON ITSELF AND THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE. AN ARTERIAL CUTDOWN WAS PERFORMED AND THE GUIDEWIRE WAS REMOVED SUCCESSFULLY. THE PATIENT WAS HELD OVERNIGHT AND RELEASED THE NEXT DAY.

  Patient problems: Insufficient Information

  MAUDE report 10713257 ↗
• MalfunctionNov 11, 2019Detachment of Device or Device Component; Device Damaged by Another Device; Material Twisted/Bent; Material Split, Cut or Torn; Detachment of Device or Device Component; Device Damaged by Another Device; Material Twisted/Bent; Material Split, Cut or Torn

  DURING ATHERECTOMY OF THE TIBIAL-PERONEAL TRUNK WITH THE PANTHERIS SV CATHETER, IMAGING WAS LOST DURING ADVANCEMENT OF THE CATHETER. THE PHYSICIAN NOTED THAT HE HAD APPLIED ADDITIONAL FORCE JUST BEFORE IMAGING WAS LOST. DURING RETRACTION OF THE CATHETER, THE NOSECONE DETACHED FROM THE CANNULA WHILE THE CANNULA AND NOSECONE WERE WITHIN THE SHEATH AND BOTH WERE WITHDRAWN FROM THE PATIENT. NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THE SHEATH AND GUIDEWIRE DID NOT HAVE TO BE REMOVED. THE PROCEDURE CONTINUED WITH ANOTHER PANTHERIS SV DEVICE ADVANCED THROUGH THE SHEATH AND WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY OR HARM. THE IFU FOR THIS DEVICE STATES AS A PRECAUTION FOR THE USER TO DETERMINE THE CAUSE OF RESISTANCE TO MOVEMENT OF THE CATHETER BEFORE CONTINUING TO MOVE THE DEVICE AGAINST RESISTANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306209 ↗
• MalfunctionAug 8, 2019Detachment of Device or Device Component; Device Damaged by Another Device; Material Split, Cut or Torn; Detachment of Device or Device Component; Device Damaged by Another Device; Material Split, Cut or Torn

  AFTER SUCCESSFUL TREATMENT OF ANTERIOR TIBIAL ARTERY, THE NOSECONE KINKED WHILE REMOVING THE DEVICE AGAINST RESISTANCE. THE GUIDEWIRE LUMEN WAS REMOVED FROM THE CATHETER, BUT IT REMAINED ON THE GUIDEWIRE. DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY OR HARM. THE IFU FOR THIS DEVICE STATES A PRECAUTION TO DETERMINE THE CAUSE OF RESISTANCE TO MOVEMENT OF THE CATHETER BEFORE PROCEEDING WITH MANIPULATION OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876042 ↗
• MalfunctionAug 7, 2019Detachment of Device or Device Component; Device Damaged by Another Device; Material Twisted/Bent; Material Split, Cut or Torn; Detachment of Device or Device Component; Device Damaged by Another Device; Material Twisted/Bent; Material Split, Cut or Torn

  TARGET LESION WAS NOTED TO BE SIGNIFICANTLY CALCIFIED. PHYSICIAN NOTED HE USED SIGNIFICANT FORCE IN ORDER TO ATTEMPT TO CROSS THE LESION, HOWEVER, GIVEN THE LESION CHARACTERISTICS THE CATHETER WOULD NOT CROSS. AT THIS POINT THE LESION WAS PRE-DILATED WITH AN ANGIOPLASTY BALLOON. THE CATHETER WAS THEN RE-INSERTED AND WAS ABLE TO CROSS WITHOUT ISSUE. IT WAS NOTED THAT THERE WAS NO OCT IMAGE AND POSSIBLE FIBER BREAK. THE DEVICE WAS THEN WITHDRAWN INTO THE SHEATH. THE PHYSICIAN NOTED THAT HE HAD TO APPLY ADDITIONAL FORCE AT THE ILIAC BIFURCATION TO WITHDRAW THE DEVICE. AT THIS POINT, THE NOSECONE DETACHED IN THE SHEATH AND WAS CONTAINED WITHIN THE SHEATH. THE SHEATH WAS REMOVED ALONG WITH THE NOSECONE WHICH WAS CONTAINED WITHIN THE SHEATH. NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THE GUIDEWIRE DID NOT HAVE TO BE REMOVED. A NEW SHEATH WAS INSERTED, AND INTERVENTION CONTINUED WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY OR HARM. THE IFU FOR THIS DEVICE STATES A PRECAUTION TO DETERMINE THE CAUSE OF RESISTANCE TO MOVEMENT OF THE CATHETER BEFORE PROCEEDING WITH MANIPULATION OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870791 ↗