MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number	M00562321
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific corporation became aware of the following events through the article "antimicrobial prophylaxis in patients undergoing endoscopic mucosal resection for 10- to 20-mm colorectal polyps" written by linfu zheng, et.Al.The study aimed to investigate the clinical impact of using prophylactic antibiotics during the perioperative period of endoscopic mucosal resection (emr) for colorectal polyps.According to the literature, a total of 246 patients who met the inclusion criteria underwent endoscopic mucosal resection at the 900th hospital of pla for emr from january 2016 to november 2019.It was reported that 22 patients had mild abdominal pain that was relieved by a spasmolytic.In addition, 21 cases of delayed bleeding were observed after the emr procedure.The bleeding was controlled with clips, and there was no subsequent bleeding.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: it was reported that the procedures were between (b)(6) 2016 and (b)(6) 2019.Block d4, h,4: the suspect device upn and lot number are not reported; therefore, the manufacture and expiration dates are unknown.Block g3: literature source journal article: zheng l, jiang l, li d, chen l, jiang c, xie l, zhou l, huang j, liu m, wang w."antimicrobial prophylaxis in patients undergoing endoscopic mucosal resection for 10- to 20-mm colorectal polyps: a randomized prospective study." medicine 2022;101:50(e31440).Block h6: imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17166696
• Report Number: 3005099803-2023-03146
• Device Sequence Number: 5757321
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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 Model Number: M00562321
• Device Catalogue Number: 6232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown