IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DELIVERY CATHETER WAS USED DURING A GALLSTONE FRAGMENTATION PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE SPYSCOPE WAS USED ALONG WITH A LASER TO SUCCESSFULLY COMPLETE THE PROCEDURE, BUT UPON REMOVAL FROM THE ENDOSCOPE, THE PHYSICIAN NOTED A CRACK NEAR THE DISTAL END OF THE DEVICE. NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE AND NO PART OF THE SPYSCOPE DETACHED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS GOOD.
D
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DELIVERY CATHETER WAS USED DURING A GALLSTONE FRAGMENTATION PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE SPYSCOPE WAS USED ALONG WITH A LASER TO SUCCESSFULLY COMPLETE THE PROCEDURE , BUT UPON REMOVAL FROM THE ENDOSCOPE THE PHYSICIAN NOTED A CRACK NEAR THE DISTAL END OF THE DEVICE. NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE AND NO PART OF THE SPYSCOPE DETACHED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS GOOD.
N
Patient 1
ALTHOUGH, THE EXACT PATIENT INFORMATION IS UNKNOWN, THE PATIENT IS OVER 18 YEARS OF AGE. (B)(4) FOR THE REPORTED EVENT OF CATHETER CRACKED. ALTHOUGH, THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
N
Patient 1
A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT A 1MM SPLIT WAS PRESENT NEAR THE DISTAL TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DISTAL END OF THE CATHETER WAS CRACKED. THE EVALUATION IDENTIFIED A SPLIT IN THE CATHETER NEAR THE DISTAL TIP. THIS DAMAGE MAY HAVE OCCURRED DURING THE MANUFACTURING PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURE. THERE IS AN OPEN SUPPLIER CORRECTIVE ACTION TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).