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 # 3005099803-2022-00674 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.

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 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 february 21, 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.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results: a rotatable small oval med stiff snare was received for analysis.Visual and functional inspections of the returned device revealed no problems had been found.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of "loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual and functional test.Additionally, the electrical test passed.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: blocks b5, h6 (device codes), and h10 have been updated based on the additional information received on february 21, 2022.

• 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: 13559411
• MDR Text Key: 286886818
• Report Number: 3005099803-2022-00671
• 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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