PULL PEG SD 20FR
Received Aug 14, 2006 · Event occurred Jul 10, 2006
Report 1720496-2006-00232 · MDR key 771892
Device
Product problems
- Detachment Of Device Component
- Device, or device fragments remain in patient
Patient
*
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
A DETACHMENT OF THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 180 DAYS. THE DOME PORTION WAS STILL IN THE PT AT THE TIME OF REPORTING.
Additional Manufacturer Narrative
THE COMPLAINT OF BREAK IN THE FEEDING TUBE IS CONFIRMED, USER-RELATED. THE CROSS SECTIONAL VENEER IDENTIFIED AT THE BREAK SITE ARE TRAITS INDICATIVE OF EXCESSIVE FORCE THAT WAS APPLIED DURING REMOVAL OF THE DEVICE. THE LACK OF ANY ASSOCIATED DAMAGE SUGGESTS THE BREAK WAS CAUSED BY STRETCHING THE FEEDING TUBE BEYOND ITS ELASTIC LIMITS DURING REMOVAL. THE BREAK IN THE FEEDING TUBE IS JUST PROXIMAL TO THE RETENTION DOME. THIS WAS CONFIRMED BY COMPARING THE COMPLAINT SAMPLE WITH A NON-COMPLAINT SAMPLE. THE BROKEN RETENTION DOME WAS NOT RETURNED FOR EVALUATION. IT IS NOT KNOWN IF THE GASTROSTOMY TUBING WAS FREE-FLOATING WITHIN THE FIBROUS TRACT PRIOR TO REMOVAL. THE DEVICE HAD BEEN IN PLACE FOR APPROX 180 DAYS PRIOR TO THE COMPLAINT INCIDENT. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS AND TACTUAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDES A NARRATIVE DESCRIPTION FOR REMOVAL OF THIS DEVICE.