SOLOPATH SR-1935Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00852381004357), received between Dec 15, 2016 and Oct 19, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Kinked” (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 16, 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.

• MalfunctionOct 19, 2018Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THE SOLOPATH RE-COLLAPSIBLE SR1935 BALLOON COULD NOT BE INFLATED TO COLLAPSE THE SHEATH AT THE END OF THE PROCEDURE. THE SOLOPATH DEVICE WAS REMOVED FROM THE PATIENT. THE BALLOON WAS CHECKED (BY INFLATION) ONCE OUTSIDE OF THE PATIENT, AND THERE WAS A LEAKAGE OF THE BALLOON IN THE DISTAL PART. IN THE ILIAC ARTERY THERE WAS SOME CALCIFICATIONS THAT COULD HAVE BEEN THE REASON FOR THE LEAKAGE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. THE SIZE OF THE SOLOPATH DID NOT MATCH THE SIZE OF THE TAVI DEVICE (AS RECOMMENDED), SO THE USE WAS FOR OTHER PURPOSE DURING THE PROCEDURE AND FOR IN SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985868 ↗
• InjuryOct 11, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT IT WAS EASY TO PLACE THE SOLOPATH. DILATATION FOR 1 MINUTE. IT WAS NOT POSSIBLE TO INTRODUCE THE IVAC CATHETER TROUGH THE SHEATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: DURING ANGIO THE RECOGNIZED A NICK IN THE SHEATH. THEN THEY REMOVED THE CATHETER AND DILATE THE SOLOPATH AGAIN FOR ONE MINUTE. DURING ANGIO THEY STILL RECOGNIZED THE NICK - AGAIN DILATATION. THEY AGAIN TRIED TO MOVE THE CATHETER FORWARD, BUT WITHOUT ANY SUCCESS. CATHETER AND SOLOPATH WAS REMOVED. IT WAS REPORTED THAT THERE WAS A SIGNIFICANT BLOOD LOSS - 500ML. ADDITIONAL INFORMATION WAS RECEIVED ON 9/19/2017: BOTH SOLOPATHS REPORTED (0870 AND 0871) HAD BEEN IN THE SAME PATIENT, WHILE THE SAME PROCEDURE. BOTH OF THEM HAVE HAD A KINKING. BLOOD LOSS WAS ONLY AT THE FIRST ONE. A FEW DAYS BEFORE, THE PATIENT HAD AN ACUTE MYOCARDIAL INFARCTION. WHILE AN ANGIO THE PHYSICIAN DIAGNOSED A THREE VESSEL CHD WITH MULTIPLE STENOSIS AND A LOW EF. BECAUSE OF THAT, IT WAS A HIGH RISK PCI.

  Patient problems: Blood Loss

  MAUDE report 6940988 ↗
• MalfunctionOct 11, 2017Kinked; Kinked

  THE USER FACILITY REPORTED THAT AFTER INTRODUCTION THEY COULD RECOGNIZE A NICK AT THE SHEATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER: PHYSICIAN COULD INTRODUCE THE IVAC CATHETER OVER THE NICK INTO THE AORTA WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT THE PATIENT WAS HIGH RISK. IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. IT WAS REPORTED THAT THE BLOOD LOSS WAS ABOUT 500 ML DURING PCI. ADDITIONAL INFORMATION WAS RECEIVED ON 9/19/17: BOTH SOLOPATHS REPORTED (0870 AND 0871) HAD BEEN IN THE SAME PATIENT, WHILE THE SAME PROCEDURE. BOTH OF THEM HAVE HAD A KINKING. A FEW DAYS BEFORE, THE PATIENT HAD AN ACUTE MYOCARDIAL INFARCTION. WHILE AN ANGIO THE PHYSICIAN DIAGNOSED A THREE VESSEL CHD WITH MULTIPLE STENOSIS AND A LOW EF. BECAUSE OF THAT, IT WAS A HIGH RISK PCI.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6940964 ↗
• InjuryDec 15, 2016Entrapment of Device; Entrapment of Device

  THE USER FACILITY REPORTED THAT THE SOLOPATH DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT DURING A CASE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: PREPARING FOR TABR, PATIENT HAD SMALL ILIAC APPROXIMATELY 4.5MM; SLIGHT CALCIFICATION EXCEPT AT THE BIFURCATION WHERE MODERATE CALCIFICATION WAS NOTED; THREE DILATORS IN INCREMENTAL SIZE WERE USED TO PRE-DILATE PRIOR TO ATTEMPTING TO INSERT THE EVOLUTE CORE VALVE DEVICE; ABLE TO PASS THE DEVICE AND WHEN IT WAS RETRIEVED IT WAS NOTED TO HAVE SOME INTIMA ON THE DEVICE; WHEN THE DEVICE WAS REMOVED, A SOLOPATH WAS THEN PLACED AND INFLATED PER PROTOCOL; THE CORE VALVE WAS CLEANED OFF AND RE-INSERTED; IT STILL WOULD NOT PASS THROUGH THE ILIAC; AFTER SEVERAL ATTEMPTS THE CORE VALVE WAS REMOVED; THE SOLOPATH WAS DEFLATED PER PROTOCOL AND BECAME STUCK; GENTLE QUARTER TURNS WERE MADE AND THE DEVICE WAS REMOVED WITH PART OF THE ILIAC ARTERY ATTACHED; BLOOD LOSS WAS LESS THAN 250CC; THE PATIENT RECEIVED A FEM BYPASS; AND IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND WILL BE TRANSFERRED TO (B)(6) FOR SUBCLAVIAN APPROACH VALVE IMPLANT.

  Patient problems: Blood Loss

  MAUDE report 6178526 ↗