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

Model Number M00562451

Device Problem Failure to Deliver Energy (1211)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, an energization problem has occurred, so the device was discontinued.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.The reported health care facility's address is (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported health care facility's address is (b)(6).Block h6: problem code a090402 captures the reportable event of device unable to deliver energy.Block h10: investigation results: a captivator small hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed no problems had been found.Functional inspection was performed and device contracted and extended well.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of device failure to deliver energy could not be confirmed since the device passed the electrical test and cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.There were no problems found during visual, functional and electrical tests of 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.Block h11: block b5 has been updated based on the additional information received on june 5, 2022.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, an energization problem has occurred, so the device was discontinued.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information received on june 05, 2022/there were no visible issues noted with the cautery pin.

• 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: 14577136
• MDR Text Key: 294051070
• Report Number: 3005099803-2022-02965
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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