Model Number M00545000 |
Device Problem
Bent (1059)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/24/2014 |
Event Type
malfunction
|
Event Description
|
It was reported to boston scientific corporation that an rx cytology brush was opened for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during preparation a functional test was performed and difficulty was encountered during extension and retraction of the brush.It was reported that the bristled portion of the device was bent, and the brush fibers were bending as well, causing the brush to appear as though it was oriented differently.The procedure was completed with another rx cytology brush.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 good.
|
|
Manufacturer Narrative
|
Reported event of brush bent.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.
|
|
Manufacturer Narrative
|
Investigation results: visual evaluation found that the pull wire was bent approximately 3.2cm from the distal end; the bristled portion of the brush was not bent.Some blue paint was peeled off at the distal tip of the catheter, and the handle was bent approximately 4.0cm from the thumb ring.Functional evaluation found that the device was difficult to actuate.The brush could only partially retract due to the bend in the pull wire.It is most likely that the pull wire was bent during handling of the device, which would impact its ability to extend and retract due to increased resistance.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no other complaints exist for the specified batch.
|
|
Event Description
|
It was reported to boston scientific corporation that an rx cytology brush was opened for use in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during preparation a functional test was performed and difficulty was encountered during extension and retraction of the brush.It was reported that the bristled portion of the device was bent, and the brush fibers were bending as well, causing the brush to appear as though it was oriented differently.The procedure was completed with another rx cytology brush.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 good.
|
|
Search Alerts/Recalls
|