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

Model Number M00562690

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the suspect device upn and lot number are provided however they do not populate; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of loop detached.

Event Description

It was reported to boston scientific corporation that a sensation small oval flexible snare was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2023.During the procedure, the stent became lodged in the working channel, causing the loop of the snare to break away from the wire.The procedure was completed with an exalt scope.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; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17484611
• MDR Text Key: 321068426
• Report Number: 3005099803-2023-04107
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729748106
• UDI-Public: 08714729748106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

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: M00562690
• Device Catalogue Number: 6269S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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