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

Model Number M00561600

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

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 during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the captivator device was used; however, the suture had snapped and bands could not placed anymore.The procedure was successfully completed with an unknown device.There were no patient complications reported 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: 10867791
• MDR Text Key: 217132868
• Report Number: 3005099803-2020-05568
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0025844809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1