Model Number M00518251 |
Device Problem
Occlusion Within Device (1423)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(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 interject¿ needle was used during a hemostasis or an injection before emr procedure.According to the complainant, during the procedure it is impossible to inject any fluid inside the needle.The procedure was completed with another interject¿ needle.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.
|
|
Manufacturer Narrative
|
Investigation results: an interject needle was returned for analysis.A visual evaluation of the returned device revealed that the metal needle was present, properly bonded, and without issue.No visual defects were noted.A functional evaluation with the working length formed into two 2¿ diameter loops found that the needle would extend and retract without issue.The handle operation was smooth when actuating the device.A second functional inspection was performed, a spare lab syringe was filled with water, with a lot of force water was pushed through the device and some drops were able to pass through.The device was disassembled and an occlusion was found blocking the inner sheath at the proximal side of the needle.The reported complaint that the needle was noticed to be occluded was confirmed.Based on the information available and the analysis performed the complaint will be documented as "manufacturing execution error", the manufacturing process was not executed as validated/as designed.There is an investigation to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
|
|
Event Description
|
It was reported to boston scientific corporation that an interject¿ needle was used during a hemostasis or an injection before emr procedure.According to the complainant, during the procedure it is impossible to inject any fluid inside the needle.The procedure was completed with another interject¿ needle.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.
|
|
Search Alerts/Recalls
|