MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00562651

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

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

Event Date 11/23/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was used in the colon during a colonoscopic polypectomy procedure performed on (b)(6) 2021.During the procedure, the snare did not energize and the device could not remove the target polyp.It was noted that the snare loop was embedded into the polyp.The snare was cut and removed using biopsy forceps.The procedure was completed through multiple small resections using another sensation snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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.

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was used in the colon during a colonoscopic polypectomy procedure performed on (b)(6) 2021.During the procedure, the snare did not energize and the device could not remove the target polyp.It was noted that the snare loop was embedded into the polyp.The snare was cut and removed using biopsy forceps.The procedure was completed through multiple small resections using another sensation snare.There were no patient complications reported as a result of this event.Additional information received on january 17, 2022.After the first snare was cut and removed using biopsy forceps, a second sensation snare was used and was unable to be energized even with the physician changing the power setting.The procedure was completed with a third sensation snare.There were no patient complications.Note: this report pertains to the first of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-08192 and 3005099803-2022-00545 for the associated device information.

Manufacturer Narrative

Block h6: problem code a150208 captures the reportable event of snare loop entrapment.Problem code a050702 captures the reportable event of snare unable to cut the target polyp.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 was disposed and will not be returned for evaluation; 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 has been updated based on the additional information received on january 17, 2022.

• Brand Name: SENSATION SHORT THROW
• 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: 13255551
• MDR Text Key: 288995581
• Report Number: 3005099803-2021-08192
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: M00562651
• Device Catalogue Number: 6265
• Device Lot Number: 0026956694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female