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

Model Number	M00562341
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during a polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, the snare cut the polyp but didn't cauterize.They could hear the pedal was working but electrical energy wasn't working at all.An artery was cut and a clip was placed and the patient had to be admitted for re-embolization of polypectomy.The patient was admitted for two days with blood administered.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during a polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, the snare cut the polyp but didn't cauterize.They could hear the pedal was working but electrical energy wasn't working at all.An artery was cut and a clip was placed and the patient had to be admitted for re-embolization of polypectomy.The patient was admitted for two days with blood administered.***additional information received on april 14, 2022*** per medwatch report, the erbe machine was checked then the green light was on informing that pad was in good placement and would be safe to cautery cut the polyp.However, the cautery was unable to cauterize the area and patient developed arterial bleed.They applied clips and epinephrine was injected and then the patient was discharged.Later that evening, the patient developed additional bleeding and was admitted to the hospital for re-embolization procedure.They performed the procedure and the patient was discharged after two days.
Additional Manufacturer Narrative
Block g2: report source (user facility) maude report mw5108459 received on april 14, 2022.Block h6: patient code e0506 captures the reportable event of hemorrhage/bleeding.Impact code f08 captures the reportable event of hospitalization.Impact code f2302 captures the reportable event of blood transfusion.Impact code f23 captures the reportable event of the required intervention and the re-embolization of polypectomy.Medical device problem code a090402 captures the reportable event of device unable to deliver energy.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: blocks b5 (describe event or problem), g2 (report source), and block h10 (additional mfr narrative) has been updated based on the additional information received on april 14, 2022.Correction: block b2 (outcomes attrib to adv event).
Additional Manufacturer Narrative
Block g2: report source (user facility) maude report mw5108459 received on april 14, 2022.Block h6: patient code e0506 captures the reportable event of hemorrhage/bleeding.Impact code f08 captures the reportable event of hospitalization.Impact code f2302 captures the reportable event of blood transfusion.Impact code f23 captures the reportable event of the required intervention and the re-embolization of polypectomy.Medical device problem code a090402 captures the reportable event of device unable to deliver energy.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: correction: block d4 (lot number) the reported lot number is 0028494728; however the lot number listed in the medwatch form is 0028201832.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during a polypectomy procedure performed on (b)(6), 2022.It was reported that during the procedure and inside the patient, the snare cut the polyp but didn't cauterize.They could hear the pedal was working but electrical energy wasn't working at all.An artery was cut and a clip was placed and the patient had to be admitted for re-embolization of polypectomy.The patient was admitted for two days with blood administered.The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Additional information received on april 14, 2022 per medwatch report, the erbe machine was checked then the green light was on informing that pad was in good placement and would be safe to cautery cut the polyp.However, the cautery was unable to cauterize the area and patient developed arterial bleed.They applied clips and epinephrine was injected and then the patient was discharged.Later that evening, the patient developed additional bleeding and was admitted to the hospital for re-embolization procedure.They performed the procedure and the patient was discharged after two days.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14044756
• Report Number: 3005099803-2022-01637
• Device Sequence Number: 11963139
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2024
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0028201832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 05/24/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/10/2022; 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown