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

Model Number	M00561610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used in the esophagus during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the suture broke in the working channel of the scope.Reportedly, the bands fell off the device inside of the patient.Two of the bands were retrieved from the back of the throat using forceps, and three bands migrated into the stomach.The sixth band could not be located so a bronchoscope was used to check the lungs.The bronchoscopy confirmed that the sixth band did not migrate to the patient's lungs.The procedure was completed with a different device.There was no serious injury nor adverse patient effects as a result of this event.

• 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: 9699203
• Report Number: 3005099803-2020-00406
• Device Sequence Number: 2423105
• Product Code: FDI
• UDI-Device Identifier: 08714729842699
• UDI-Public: 08714729842699
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 08/24/2020
• Device Model Number: M00561610
• Device Catalogue Number: 50661
• Device Lot Number: 0024546281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention