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

Model Number M00560321

Device Problem Failure to Cut (2587)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a050702 captures the reportable event of loop unable to cut.

Event Description

Note: this report pertains to one of the four devices used during the same procedure.Refer to manufacturer report 3005099803-2023-02789, 3005099803-2023-02787 and 3005099803-2023-02788 for the associated device information.It was reported to boston scientific corporation that a sensation small oval med stiff snare was used during a colonoscopy procedure performed on an unknown date.During the procedure, the physician and the technician tried to remove a polyp with a sensation small oval med stiff snare in the ascending colon.However, the snare loop was not cutting through the polyp.After opening three more snares, the physician finally removed the polyp.The procedure was completed with a similar sensation short throw.There were no patient complications reported as a result of this event.

• 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; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17019366
• MDR Text Key: 316129239
• Report Number: 3005099803-2023-02786
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1