MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00561600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.It was reported that during the procedure, the string broke.The procedure was completed successfully.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code a0401 captures the reportable event of suture break.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 failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.It was reported that during the procedure, the string broke.The procedure was completed successfully.There were no patient complications reported as a result of this event.Additional information received on april 30, 2021: it was reported to boston scientific corporation that a captivator emr device was used in the gastric antrum and the procedure was completed with this device.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.It was reported that during the procedure, the string broke.The procedure was completed successfully.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021*** it was reported to boston scientific corporation that a captivator emr device was used in the gastric antrum and the procedure was completed with this device.
Additional Manufacturer Narrative
Block h6: device problem code a0401 captures the reportable event of suture break.Block h10: investigation results the returned captivator emr device was analyzed, and a visual evaluation noted that there were four bands remained attached on the ligator head, and some of the bands had overlapped on each other.Some teeth of the ligator head were bent and damaged, indicating a deployment failure.The trip wire was partially rolled in the handle assembly.The suture was intact, and was attached to the distal trip wire loop.The trip wire was severely kinked and broken.Microscope examination was performed on the broken ends of the trip wire, and it was noted that the necked region was observed, indicating the material was submitted to some tension and it was observed the teeth of the ligator head bent.A functional evaluation was performed by rotating the handle knob 120 degrees and an audible click was heard.No damage observed to the handle and no other issues with the device were noted.The reported event of suture broken was not confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CAPTIVATOR EMR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11772088
• Report Number: 3005099803-2021-01981
• Device Sequence Number: 3104685
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2021

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: 12/30/2021
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0026653069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 04/30/2021; 06/04/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/07/2021; 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 77