SPYSCOPE ACCESS & DELIVERY CATHETER
Received Jul 15, 2009 · Event occurred Jun 15, 2009
Report 3005099803-2009-03332 · MDR key 1414352
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
80 YR
- Perforation
Narrative
Description of Event or Problem
NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2009-03331 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER AND A SPYBITE BIOPSY FORCEPS WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE COMMON BILE DUCT OR THE DUODENUM MAY HAVE BEEN PERFORATED WITH THE SPYBITE OR THE ERCP SCOPE. THE PT WAS BEING CLOSELY MONITORED AND A SURGICAL DECISION HAD NOT BEEN MADE AT THAT TIME. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAS NOT YET BEEN GATHERED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.