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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Stenosis (2263)

Event Date 02/01/2022

Event Type  Injury  

Event Description

Boston scientific became aware of multiple events involving captivator emr devices through the article "multi-band mucosectomy for neoplasia with barret's esophagus: in vivo comparison between two different devices" written by marco spadaccini, et al.According to the literature, the aim to the study was to compare the efficacy and safety of two different types of band ligator: duette and captivator emr device for neoplasia in patients with barreett's esophagus during multi-band mucosectomy procedure.The randomized controlled study was carried out on seventy-six patients (38 per group).The two groups did not differ in terms of baseline characteristics.During the procedure minor bleeding was recorded in 4 patients treated with captivator emr device.All cases were managed endoscopically during the same procedure by using conventional hemostatic tools not requiring the interruption of the procedure.One patient experienced post-procedural bleeding and was admitted with melena which required endoscopic hemostasis (no transfusions needed).Three patients developed a symptomatic stricture requiring endoscopic dilation (either pneumatic or mechanical) and one of the patients required surgery for refractory stenosis.No perforations occurred in two groups.No further information has been obtained good faith efforts.

Manufacturer Narrative

Literature source: marco spadaccini, et al."multi band mucosectomy for neoplasia in patients with barrett's esophagus: in vivo comparison between two different devices" (b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 13861843
• MDR Text Key: 287689840
• Report Number: 3005099803-2022-01522
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention