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

Model Number	M00562301
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a captivator, snare was used during a procedure performed on (b)(6) 2025.During the procedure, the snare could not be fully extended, which led to longer treatment duration, increased bleeding at the wound site, and multiple attempts were required afterward to achieve hemostasis.The procedure was completed with another captivator, snare device.No further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Block e1: initial reporter first name: (b)(6).Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage major.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage major.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h2 (additional information): block a1, block a2 (age at time of event, unit of measure - age), block a3a (sex) ,block a3b (gender) block a4 (weight nit of measure - weight) block b5, block d4 (model number and catalog number), block e1 (initial reporter title, initial reporter first name, initial reporter last name, initial reporter address1) , block e3 (occupation) and block h6 (impact codes) have been updated based on the additional information received on may 29, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a captivator - -snare was used during a procedure performed on (b)(6) 2025.During the procedure, the snare could not be fully extended, which led to longer treatment duration, increased bleeding at the wound site, and multiple attempts were required afterward to achieve hemostasis.The procedure was completed with another captivator - snare device.Additional information received on may 29, 2025: the procedure performed was a resection of colonic polyps in the colon.The procedure was delayed for 15 minutes.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22095549
• Report Number: 3005099803-2025-02439
• Device Sequence Number: 15459441
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 58 KG