MALECOT
Received Oct 11, 2016
Report 2134265-2016-08919 · MDR key 6018417
Device
Generic name
Catheter, Peritoneal
Manufacturer
Boston Scientific - Costa Rica (coyol)Model number
M001224110Catalog number
22-411
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED A CATHETER FRACTURE OCCURRED. DURING THE NEPHROSTOMY CHANGE OF A MALECOT DRAINAGE CATHETER PLACED IN THE KIDNEY, THE TUBE FRAGMENTED UPON REMOVAL. THE REMAINDER OF THE TUBE WAS ABLE TO EXTRACTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED A FOREIGN MATERIAL ATTACH, AS PART OF OVERALL VISUAL REVISION. THE CATHETER IS BLACKENED IN DIFFERENT LOCATIONS, BROKEN AND IT IS BENT IN SEVERAL LOCATIONS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).
Description of Event or Problem
IT WAS REPORTED A CATHETER FRACTURE OCCURRED. DURING THE NEPHROSTOMY CHANGE OF A MALECOT DRAINAGE CATHETER PLACED IN THE KIDNEY, THE TUBE FRAGMENTED UPON REMOVAL. THE REMAINDER OF THE TUBE WAS ABLE TO EXTRACTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.