|
Model Number M00562650 |
Device Problems
Break (1069); Failure to Deliver Energy (1211); Entrapment of Device (1212); Retraction Problem (1536); Difficult to Open or Close (2921)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/20/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that a sensation snare was used in the hepatic flexure during an unknown procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a 30mm sensation snare was used for a reasonably large target polyp.The snare loop was unable to successfully retract and it failed to deliver energy.When the snare was eventually released and removed from the patient's anatomy, the snare appears to be broken.The procedure was rescheduled and the patient is expected to return to complete the procedure.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported to boston scientific corporation that a sensation snare was used in the hepatic flexure during an unknown procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a 30mm sensation snare was used for a reasonably large target polyp.The snare loop was unable to successfully retract and it failed to deliver energy.When the snare was eventually released and removed from the patient's anatomy, the snare appears to be broken.The procedure was rescheduled and the patient is expected to return to complete the procedure.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on december 18, 2018.The name of the procedure is polyp removal.During the procedure, the snare was difficult to close and it failed to deliver energy.Once closed, the snare became embedded in the anatomy of the polyp but was eventually released and removed from the patient's anatomy.The procedure was rescheduled and the patient was expected to return to complete the procedure on (b)(6) 2018.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
H6: problem code 1212 captures the reportable event of snare loop embedded in patient tissue.H10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.H11: b5, d4, e1, e3 and h10 have been updated based on the additional information received on december 18, 2018.
|
|
Search Alerts/Recalls
|
|
|