MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPTIVATOR¿; SNARE, FLEXIBLE

Model Number M00562371

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a captivator medium crescent snare was used in the duodenum during a plastic stent removal and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the snare loop detached inside the patient when attempting to remove a stent.The detached portion was retrieved successfully with forceps and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Visual evaluation of the returned device revealed that the loop was detached and the loop cannula showed that the device was correctly manufactured.The device was also inspected under x-ray magnification and it was noted that there were no residues of the wire which indicates that the wire was not broken.Functional analysis was not performed due to the condition of the returned device.The reported complaint that the loop was detached was confirmed, however, the device was used in a procedure which is not in accordance with the dfu, therefore, the most probable root cause classification is user error.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation that a captivator medium crescent snare was used in the duodenum during a plastic stent removal and endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the snare loop detached inside the patient when attempting to remove a stent.The detached portion was retrieved successfully with forceps and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPTIVATOR¿
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7108888
• MDR Text Key: 94535050
• Report Number: 3005099803-2017-03628
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019381
• UDI-Public: 08714729019381
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: M00562371
• Device Catalogue Number: 6237
• Device Lot Number: 19285288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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 Outcome(s): Required Intervention