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

Model Number M00561610

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/22/2020

Event Type  Injury  

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 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
• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9699203
• MDR Text Key: 188648962
• Report Number: 3005099803-2020-00406
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729842699
• UDI-Public: 08714729842699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention