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CASHMERE SRC141230-20Recalls & reported problems

Medos International Sàrl · CASHMERE microcoil CASHMERE 14 Stretch Resistant Coil 12mm x 30cm 190cm Contents: 1 Detachable Coil System · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528004073), received between Sep 9, 2020 and Sep 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure to Advance1
  • Stretched1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2020Stretched; Failure to Advance; Stretched; Failure to Advance

    THE HEALTHCARE PROFESSIONAL REPORTED THAT AFTER A SUDDEN SEVERE HEADACHE FOLLOWED BY SYNCOPE DURING PHYSICAL EXERCISE, THE (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED ON INTAKE CRANIAL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED SPONTANEOUS SUBARACHNOID HEMORRHAGE, FISHER GRADE III, HUNT-HESS II, EVOLVING WITH COMA ONE HOUR AFTER HOSPITAL ADMISSION. THE PATIENT UNDERWENT AN EMERGENCY CEREBRAL ANGIOGRAPHY OF THE SIX VESSELS, FOLLOWED BY EMBOLIZATION OF A LARGE ANEURYSM IN AN OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, WHEN THE FIRST COIL, A 12MM X 30CM CASHMERE 14 PLATINUM COIL (SRC14123020 / L12872) WAS BEING INTRODUCED INTO THE CONCOMITANT 150CM X 5CM PROWLER SELECT LPES MICROCATHETER (606S155X / 30023533), IT WAS NOTED THAT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER DURING COIL ADVANCEMENT ON THE INITIAL POSITIONING OF THE COIL THROUGH THE MICROCATHETER TO REACH THE TARGET ANEURYSM. AS A RESULT, IT WAS NOT VIABLE TO POSITION, OR MANEUVER THE COIL WITHIN THE ANEURYSM. THE COIL BECAME STUCK IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE COIL COMBINATION AND REPLACED BOTH THE COIL AND THE MICROCATHETER. IT WAS RE

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10511483 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.