MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number	M00561311
Medical Device Problem Codes	Failure to Deliver Energy (1211); Entrapment of Device (1212)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6) 2019 as no event date was reported.(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 or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that during the removal of a large polyp, the snare failed to coagulate.The scalpel generator and patch were replaced, however, the snare was unable to deliver energy.When attempting to retrieve the snare, the snare loop was stuck on the polyp and was unable to be removed.Reportedly, the snare was removed from the patient by cutting the polyp without cautery (cold) and a second captivator snare was used to complete cutting and coagulate in order to stop the bleeding.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 Manufacturer Narrative
Block b3 (date of event): date of event was approximated to be may 01, 2019 as no event date was reported.Block h6: device problem code 1212 captures the reportable event of snare loop embedded in polyp.Block h10: investigation results: visual analysis of the returned device revealed that the device and cautery were in good condition.Electrical resistance test was performed and it measured 10.5 ohms, within manufacturing specification.Functional evaluation revealed that the device extends and retracts within specification.Based on the information available and the analysis performed, the most probable root cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that during the removal of a large polyp, the snare failed to coagulate.The scalpel generator and patch were replaced, however, the snare was unable to deliver energy.When attempting to retrieve the snare, the snare loop was stuck on the polyp and was unable to be removed.Reportedly, the snare was removed from the patient by cutting the polyp without cautery (cold) and a second captivator snare was used to complete cutting and coagulate in order to stop the bleeding.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.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8680079
• Report Number: 3005099803-2019-02567
• Device Sequence Number: 2221216
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0022776289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1