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

Model Number M00561221

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, when testing the snare prior to insertion, the snare did extend and retract but had a slight resistance and did not open and shut as smoothly as normal.After insertion into the scope and lining up beside the polyp, the snare would not sit or lie flat on the mucosal surface since the wire appeared to be curved.Additionally, the snare did not close well, then jumped through the tissue and cut without normal control.Reportedly, there were no issues noted with the handle.The snare was able to extend/retract after it was removed from the scope/patient but there was abnormal resistance noticed.Moreover, there were 3 other snares that were used on different patients that had similar issues that day.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable and fine.

• 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.; 256 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10593062
• MDR Text Key: 208758634
• Report Number: 3005099803-2020-04212
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• 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