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

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 06/13/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an unknown snare was used during a stent removal 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 a olympus 190.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Block d4, h4: the suspect device upn and lot number is not reported; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of loop detached.Block d1 and block d2a have been updated based on additional information received august 14, 2023.

Event Description

It was reported to boston scientific corporation that an unknown snare was used during a stent removal 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 a olympus 190.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR II
• 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: 17260270
• MDR Text Key: 318799544
• Report Number: 3005099803-2023-03580
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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