MALECOT
Received Jun 26, 2013 · Event occurred May 28, 2013
Report 2134265-2013-04337 · MDR key 3191465
Device
Generic name
Catheter, Peritoneal
Manufacturer
Boston Scientific - SpencerModel number
M001224110Catalog number
22-411
Lot number
0015714630
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING A UNSPECIFIED PROCEDURE DEVICE BREAKAGE OCCURRED. A MALECOT CATHETER HAD BEEN ADVANCED AND AT AN UNSPECIFIED TIME, THE DISTAL PORTION OF THE CATHETER BROKE OFF IN THE PATIENT'S STOMACH. A GASTROSTOMY WAS PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE