CASHMERE SRC141025-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528004059), received between Nov 16, 2016 and Dec 6, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2016Kinked; Physical Resistance; Kinked; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A CASHMERE ((B)(4)) COULD NOT BE ADVANCED THROUGH AN SL 10 MICROCATHETER, THE DISTAL END OF THE COIL WAS KINKED, AND THE SHEATH DISLODGED DURING RESHEATHING AND A GALAXY G2 ((B)(4)) WAS DIFFICULT TO ADVANCED AND WAS FOUND TO BE STRETCHED UPON REMOVAL AND WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. INITIALLY, USING AN ENVOY DA AND SL10 MICROCATHETER, A HELIPAQ 10 X 30 WAS ADVANCED WITHOUT ISSUE. THE COMPLIANT CASHMERE 10 X 14 WOULD NOT BE ADVANCED INTO THE SL 10 MICROCATHETER AND WHEN REMOVED, THE DISTAL END WAS KINKED. WHEN ATTEMPTING TO RE-SHEATH THE COIL, THE SHEATH DISLODGED (THE WIRE CAME THROUGH THE SHEATH). A SYNCRO 2 WIRE WAS INTRODUCED TO CHECK FOR A KINK IN THE SYSTEM, BUT NO KINK WAS FOUND. NEXT A 9 X 25 GALAXY 2 COIL WAS INTRODUCED INTO THE MICROCATHETER AND THE LAST 8-10 INCHES WAS TOO DIFFICULT TO ADVANCED FURTHER. UPON TRYING TO REMOVE THE COIL, THE COIL STRETCHED INSIDE THE MICROCATHETER, AND BOTH WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR¿S COIL. IT WAS REPORTED THAT THERE WAS A 25 MINUTES DELAY TO SELECT NEW COILS, AND NO ADDITI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6147322 ↗
• MalfunctionNov 16, 2016Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, WHILE REPOSITIONING A CASHMERE COIL (SRC14102520/ C25290) FOR TREATMENT OF AN ANEURYSM OFF THE INTERNAL CAROTID ARTERY, THE PHYSICIAN FELT THAT THE COIL WAS STRETCHING DUE TO RESISTANCE WITH THE MICROCATHETER RESULTING IN LOSS OF TARGET POSITION. THE DEVICE HAD APPEARED NORMAL PRIOR TO USE. AN SL 10 MICROCATHETER WAS USED FOR THE PROCEDURE, AND AN ADEQUATE CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. PRIOR TO THIS COIL, OTHER COILS HAD GONE THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE; HOWEVER, COIL ENTANGLEMENT DID NOT CONTRIBUTE TO THE COIL STRETCHING. THE MICROCATHETER HAD NOT BEEN REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. THE ENTIRE COIL WAS REMOVED STILL ATTACHED TO THE DPU, AND AFTER REMOVAL, THE MICROCATHETER TIP WAS REINTRODUCED INTO THE ANEURYSM. THERE WAS NO NEED FOR ADDITIONAL INTERVENTION TO REMOVE THE COIL. THE EVENT DID NOT RESTRICT BLOOD FLOW. THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS ACCIDENTALLY DISCARDED BY THE HOSPITAL STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6105480 ↗