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

Model Number M00562340

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure 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 captivator medium hexagonal stiff snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the snare loop ruptured.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: CAPTIVATOR
• 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: 8802816
• MDR Text Key: 151445831
• Report Number: 3005099803-2019-03492
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747871
• UDI-Public: 08714729747871
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K941750
• 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: 07/18/2019

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 Expiration Date: 02/18/2021
• Device Model Number: M00562340
• Device Catalogue Number: 6234
• Device Lot Number: 0021762475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• 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 Age: 58 YR