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

Model Number M00561821

Device Problems Entrapment of Device (1212); Failure to Cut (2587)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-00671 for the associated device information.It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used to remove a 10mm polyp in the colon during a colorectal polypectomy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, they attempted to cold cut the polyp the snare cannot cut well.Therefore, it was switched to energization but the cut was still bad.The snare was securely attached to the active cord.The possibility of over gripping too many mucous membranes was mentioned.A second rotatable snare of the same lot number was used, however, the device encountered the same problems.The procedure was completed with a third rotatable snare with a different lot number.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Problem code: (b)(4).Problem code: (b)(4).The complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5 and h10 has been updated based on the additional information received on (b)(6) 2022.Additional information received on (b)(6), 2022 confirmed that this event was reported to boston scientific in error and is a duplicate of another event.Report number 3005099803-2022-00674 is a duplicate of report number 3005099803-2022-00671.Therefore, this event no longer represents an mdr-reportable scenario, and all information for this event can be found under report number 3005099803-2022-00671.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-00671 and 3005099803-2022-00674 for the associated device information.It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used to remove a 10mm polyp in the colon during a colorectal polypectomy procedure performed on (b)(6), 2022.It was reported that during the procedure and inside the patient, they attempted to cold cut the polyp the snare cannot cut well.Therefore, it was switched to energization but the cut was still bad.The snare was securely attached to the active cord.The possibility of over gripping too many mucous membranes was mentioned.A second rotatable snare of the same lot number was used, however, the device encountered the same problems.The procedure was completed with a third rotatable snare with a different lot number.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2022*** only one rotatable snare was unable to cut well and the procedure was completed with a second rotatable snare.Additionally, the snare loop was not embedded in the tissue.

• Brand Name: ROTATABLE SNARE
• 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: 13559416
• MDR Text Key: 288992409
• Report Number: 3005099803-2022-00674
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0028188203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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