Model Number M00545000 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/07/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter: the physician's phone number is (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when the brush was advanced through a tight stricture the catheter was buckled.The procedure was completed with another rx cytology brush.The patient's condition at the conclusion of the procedure was reported to be stable.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
Investigation results: visual evaluation of the returned device revealed that the working length was bent and kinked in multiple places throughout.The catheter tip was undamaged and without issue.The brush bristle portion was present and properly formed.The device was extended and retracted with strong resistance.The pull wire was kinked from the tip of the brush when the device was fully extended.The bends and kinks in the device and the difficulty in engaging the target vessel were most likely due to some aspects of tortuous anatomy or other operational factors of the procedure.Therefore, the most probable root cause classification is "operational context".A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no similar complaints exist for the specified batch. .
|
|
Event Description
|
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when the brush was advanced through a tight stricture the catheter was buckled.The procedure was completed with another rx cytology brush.The patient's condition at the conclusion of the procedure was reported to be stable.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|