SPYSCOPE ACCESS AND DELIVERY CATHETER
Received Mar 28, 2011 · Event occurred Mar 7, 2011
Report 3005099803-2011-01041 · MDR key 2031855
Device
Generic name
Mini Endoscope, Gastroenterology-urology
Manufacturer
Boston Scientific - MarlboroughModel number
M00546230Catalog number
4623
Lot number
1ML0102601
Product problems
- Torn Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SYNSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE CATHETER SHEATH WAS FOUND TO BE TORN NEAR THE TIP OF THE SPY CATHETER. NO DAMAGE TO THE PACKAGE WAS VISIBLE. THE CASE WAS COMPLETED WITH ANOTHER SPYSCOPE ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Additional Manufacturer Narrative
PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT (B)(6). 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.
Additional Manufacturer Narrative
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE PEBAX WAS CUT IN THREE PLACES NEAR THE DISTAL TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE SHEATH WAS TORN NEAR THE TIP. THE EVALUATION ATTRIBUTED THIS FAILURE TO THE MANUFACTURING PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURE. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.(B)(4)
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE CATHETER SHEATH WAS FOUND TO BE TORN NEAR THE TIP OF THE SPY CATHETER. NO DAMAGE TO THE PACKAGE WAS VISIBLE. THE CASE WAS COMPLETED WITH ANOTHER SPYSCOPE ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.