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

Model Number M00562301

Device Problems Human-Device Interface Problem (2949); Mechanical Jam (2983)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a gastroscopic resection procedure performed on (b)(6) 2023.During the procedure, the tip of the snare was too sharp and could not be bent or moved flexibly, which made the procedure difficult and caused bleeding in the colon.The physician noticed the bleeding and based on the physician's assessment, the snare contributed to the bleeding.A disposable hemostatic clip was used to stop the bleeding and hemostatic treatments were given after the procedure to stop the bleeding.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf patient code e2015 captures the reportable event of tissue injury.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Manufacturer Narrative

Block h6: imdrf impact code f2301 captures the reportable event of additional device required.Imdrf device code a22 captures the reportable event of tip traumatic block h11: block h6 (impact code) has been corrected.Block h6 (device code) has been corrected.Block b5 have been updated based on additional information received on october 12, 2023 and november 8, 2023.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a gastroscopic resection procedure performed on (b)(6) 2023.During the procedure, the tip of the snare was too sharp and could not be bent or moved flexibly, which made the procedure difficult and caused bleeding in the colon.A disposable hemostatic clip was used to stop the bleeding and hemostatic treatments were given after the procedure to stop the bleeding.There were no patient complications reported as a result of this event.Based on additional information received october 12, 2023, after the polyps were removed, there was slight bleeding and the only hemostatic treatment was the use of the hemostatic clip during the procedure.There was no additional treatment after the procedure.The manufacturer has reviewed all information and determined this event did not cause and is not likely to cause serious harm.Based on additional information received on november 8, 2023, the complaint snare was sharper that other captivator snares that they have used.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a gastroscopic resection procedure performed on (b)(6) 2023.During the procedure, the tip of the snare was too sharp and could not be bent or moved flexibly, which made the procedure difficult and caused bleeding in the colon.A disposable hemostatic clip was used to stop the bleeding and hemostatic treatments were given after the procedure to stop the bleeding.There were no patient complications reported as a result of this event.Based on additional information received october 12, 2023, after the polyps were removed, there was slight bleeding and the only hemostatic treatment was the use of the hemostatic clip during the procedure.There was no additional treatment after the procedure.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

Manufacturer Narrative

Block b5 have been updated based on additional information received on october 12, 2023.Based on additional information received october 12, 2023, after the polyps were removed, there was slight bleeding and the only hemostatic treatment was the use of the hemostatic clip during the procedure.There was no additional treatment after the procedure.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• Brand Name: CAPTIVATOR
• Type of Device: 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: 17930048
• MDR Text Key: 325601208
• Report Number: 3005099803-2023-05508
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0029481532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female