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

Model Number	M00562551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific corporation became aware of the following events through the article "safety and efficacy of cold snare polypectomy for small colorectal polyps" written by takahiro ito, et al.According to the literature, 119 patients were recruited for this study and underwent polypectomy at (b)(6) hospital from (b)(6) 2015 to (b)(6) 2016.The participants were randomized, with 59 patients assigned to the cold snare polypectomy group.A total of 458 polyps were resected from the participants of both groups.Cold snare polypectomy was performed with a small oval flexible boston scientific profile snare or a medium flexible boston scientific profile snare.It was reported that a patient had delayed bleeding requiring intervention.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage major.Imdrf impact code f08 captures the reportable event of hospitalization or prolong hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a24 captures the reportable event of adverse event without identified device or use problem.
Additional Manufacturer Narrative
Block b3: it was reported that the procedures were between from may 2015 to may 2016.Block g3: literature source journal article: ito t, et al."safety and efficacy of cold snare polypectomy for small colorectal polyps: a prospective randomized control trial and one-year follow-up study." medicine 2021;100:23(e26296).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage major imdrf impact code f08 captures the reportable event of hospitalization or prolong hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
Boston scientific corporation became aware of the following events through the article "safety and efficacy of cold snare polypectomy for small colorectal polyps" written by takahiro ito, et al.According to the literature, 119 patients were recruited for this study and underwent polypectomy at asahikawa-kousei general hospital from may 2015 to may 2016.The participants were randomized, with 59 patients assigned to the cold snare polypectomy group.A total of 458 polyps were resected from the participants of both groups.Cold snare polypectomy was performed with a small oval flexible boston scientific profile snare or a medium flexible boston scientific profile snare.It was reported that a patient had delayed bleeding requiring intervention.Note: no further information has been obtained despite good faith efforts.

• Brand Name: PROFILE
• 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: 17129121
• Report Number: 3005099803-2023-03158
• Device Sequence Number: 17988893
• Product Code: FDI
• UDI-Device Identifier: 08714729156659
• UDI-Public: 08714729156659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/10/2023

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: M00562551
• Device Catalogue Number: 6255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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: Required Intervention
• Patient Sex: Unknown