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

Model Number M00561600

Device Problems Device Difficult to Setup or Prepare (1487); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device 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 two captivator endoscopic mucosal resection devices were used during a mucosectomy procedure performed in the esophagus on (b)(6) 2020.According to the complainant, during the procedure, the ligator cap did not match nor would fit at the tip of the pentax model eg-2990-i standard gastroscope.The same issue occurred with the second captivator endoscopic mucosal resection device.Reportedly, the patient was already sedated and the procedure was not completed due to this event.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: 10142985
• MDR Text Key: 194935512
• Report Number: 3005099803-2020-02260
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2020
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0024003829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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