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

Model Number M00561221

Device Problems Failure to Cut (2587); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Imdrf device code a0501 captures the reportable event of loop detached.Block d4, h4: the suspect device lot number does not populate; therefore, the manufacture and expiration dates are unknown.

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.The polyp has a size of 0.9 cm and located in the sigmoid colon.During the procedure, a snare was unpacked and inserted into the patient's intestine through the forceps canal to resect the polyp, but it did not completely remove the polyp.The snare loop broke and fell into the intestine, but it was immediately removed with forceps.The procedure was completed with a similar 10mm captivator ii round stiff snare.It was not reported if there were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Imdrf device code a0501 captures the reportable event of loop detached.Block d4, h4: the suspect device lot number does not populate; therefore, the manufacture and expiration dates are unknown.Block h11: block h6 impact code has been corrected.Block b5 has been updated based on the additional information received on september 18, 2023.

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.The polyp has a size of 0.9 cm and located in the sigmoid colon.During the procedure, a snare was unpacked and inserted into the patient's intestine through the forceps canal to resect the polyp, but it did not completely remove the polyp.The snare loop broke and fell into the intestine, but it was immediately removed with forceps.The procedure was completed with a similar 10mm captivator ii round stiff snare.It was not reported if there were no patient complications reported as a result of this event.According to additional information received on september 18, 2023, it was not reported if the forceps used to remove the snare loop is a bsc device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.The polyp has a size of 0.9 cm and located in the sigmoid colon.During the procedure, a snare was unpacked and inserted into the patient's intestine through the forceps canal to resect the polyp, but it did not completely remove the polyp.The snare loop broke and fell into the intestine, but it was immediately removed with forceps.The procedure was completed with a similar 10mm captivator ii round stiff snare.It was not reported if there were no patient complications reported as a result of this event.Additional information received on september 18, 2023: there were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Imdrf device code a0501 captures the reportable event of loop detached.Block d4, h4: the device lot number is unknown; therefore, the manufacture and expiration dates are unknown.Block h11: block h6 impact code has been corrected.Block h10 investigation results: one captivator snare was received for analysis.Visual and microscope analysis of the returned device found the loop was detached from the wire.The loop was not returned.The reported event of "loop unable to cut" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "loop detached" was confirmed since the loop was detached from the wire.An investigation to address this problem has been completed.Per procedure, there are instructions about the correct position, crimping, and how the inspection should be performed.The investigation concluded that this task was not properly executed.The most assignable cause was determined to be human error.The investigation concluded that this is an isolated event.The pull test inspection has been updated and expanded.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is manufacturing deficiency.

• Brand Name: CAPTIVATOR II
• 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: 17780630
• MDR Text Key: 323830108
• Report Number: 3005099803-2023-05008
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• 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: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR
• Patient Sex: Male