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

Model Number M00561221

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The reported healthcare facility is: (b)(6) hospital problem code (b)(4).The device has not been received for analysis; therefore, a problem 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 to be used during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and outside the patient, the actived cord connection failed and the pin was loose/separated.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 fine.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and outside the patient, the activated cord connection failed and the pin was loose/separated.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 fine.

Manufacturer Narrative

Block e1: this event was reported by the distributor.The reported healthcare facility is: (b)(4).Block h6: problem code a0501 captures the reportable event of cautery pin detached.Block h10: investigation results a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no problems were noted with the cautery pin.Additionally, the prongs of the cautery plug were noted to be good.Dimensional inspection was performed and the active cord gauge test was executed and device passed.No other problems were noted.The reported event of "cautery pin detachment" was not confirmed since no problems were noted in the cautery pin and the active cord gauge (go/no go) test was executed and device passed the test.The reported event of "device interaction with another device" was not confirmed since it was not possible to determine the compatibility of the active cord used during the procedure, and the active cord gauge (go/no go) test was executed and device passed the test.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and outside the patient, the actived cord connection failed and the pin was loose/separated.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 fine.

Manufacturer Narrative

Block e1: this event was reported by the distributor.The reported healthcare facility is: (b)(6).Block h6: problem code a0501 captures the reportable event of cautery pin detached.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: blocks d9, e1 (initial reporter facility name, initial reporter facility name, initial reporter city and initial reporter zip/post code), h3 and h10 have been updated based on the additional information received on 31aug2021 and the device return on 02sep2021.

• 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: 12392765
• MDR Text Key: 268976212
• Report Number: 3005099803-2021-04381
• 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: 09/28/2021

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: 02/16/2024
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0026802633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 08/31/2021; 09/08/2021
• Supplement Dates FDA Received: 09/03/2021; 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1