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

Model Number M00561221

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

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 ii-10mm round stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, just before polypectomy, a foreign body was noted on the tip of the snare loop.Reportedly, there were no issues noted with the inner seal package and the sterile pouch of the device.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be okay.

Manufacturer Narrative

The initial reporter's city is (b)(6).Device problem code 2944 captures the reportable event of foreign material present in device.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, just before polypectomy, a foreign body was noted on the tip of the snare loop.Reportedly, there were no issues noted with the inner seal package and the sterile pouch of the device.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be okay.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, just before polypectomy, a foreign body was noted on the tip of the snare loop.Reportedly, there were no issues noted with the inner seal package and the sterile pouch of the device.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be okay.

Manufacturer Narrative

The initial reporter's city is (b)(6).Device problem code 2944 captures the reportable event of foreign material present in device.Analysis of returned product revealed that a foreign matter was found on the loop.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.There is an investigation in place to address this issue.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8289237
• MDR Text Key: 134493072
• Report Number: 3005099803-2019-00317
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0022388294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1