MALECOT
Received Jun 25, 2013 · Event occurred May 28, 2013
Report 2134265-2013-04338 · MDR key 3187891
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
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
(B)(4). 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. ENDOSCOPIC ABLATION OF THE DISTAL END WAS PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.