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

Model Number M00562301

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(6).(b)(4).The device has been received for analysis; however 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used in the sigmoid colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the snare was extended and was applied on the target polyp, it was noted that the handle was hard and the target polyp could not be strangulated.The snare was then tried to be removed from the patient with the snare loop extended.However, the snare loop was detached.The detached piece of the snare loop remained inside the patient and there were no plans to remove the detached snare loop.The procedure was not completed due to this event.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

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.The initial reporter address is (b)(6).Problem code 2907 captures the reportable event of snare loop detached.Investigation results: a captivator snare was received for analysis.Visual evaluation of the returned device revealed that the snare loop was detached and it was not returned, however the wire seems pointy at the wire distal end.A risk analysis was performed on the document hazard analysis/product risk analysis (use and design fmea) polypectomy snares risk management workbook and was confirmed that the reported event is not a new or unanticipated failure mode and does not required to be updated.Based on case gathered evidence, an investigation was performed with the available information (product code, batch number, customer, as applicable) and efforts were taken to enable the determination of a probable cause.Since the device has loop detached, this suggests that the manufacturing process was not correctly performed.Therefore, the most probable cause for the complaint event is manufacturing deficiency.There is an investigation in place to address this issue.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corportation that a captivator small oval stiff snare was used in the sigmoid colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the snare was extended and was applied on the target polyp, it was noted that the handle was hard and the target polyp could not be strangulated.The snare was then tried to be removed from the patient with the snare loop extended.However, the snare loop was detached.The detached piece of the snare loop remained inside the patient and there were no plans to remove the detached snare loop.The procedure was not completed due to this event.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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9304916
• MDR Text Key: 184179928
• Report Number: 3005099803-2019-05157
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1