DELTEC LOGICATH CONVENTIONAL - ADULT
Received Sep 15, 2022 · Event occurred Jan 10, 2021
Report 3012307300-2022-19334 · MDR key 15433267
Device
Product problems
- Difficult to Advance
- Difficult to Advance
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE DEVICE, IT CONTACTED THE DISTAL END AND PREVENTED THE ADEQUATE PASSAGE OF THE DILATOR. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
OPERATOR OF DEVICE ARE UNKNOWN. NO INFORMATION IS PROVIDED TO DATE. FOR INVESTIGATION NO SAMPLE OR PICTURES WERE PROVIDED. THEREFORE A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE ABOVE INFORMATION IT IS FELT THAT THIS INCIDENT IS NOT DUE TO A PRODUCT FAILURE OF THE CATHETER OR GUIDE WIRE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4).