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

Model Number M00562301

Device Problems Failure to Cut (2587); Material Split, Cut or Torn (4008)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used to remove polyp in the descending colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop was not able to remove the polyp.In addition, the plastic sheath was torn.The snare was securely attached to the active cord and no problems were noted with the cautery pin.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 stable.

Manufacturer Narrative

(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 h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator small oval stiff snare was received for analysis.Visual inspection of the returned device revealed that the working length was ripped, torn and kinked.Also, the wire was kinked.Electrical test was performed and the device passed, indicating a proper connection.No other device problems were noted.The reported complaint of loop unable to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device passed electrical testing upon return.The reported complaint of working length torn was confirmed since device analysis found the working length was ripped, torn, and kinked.It is probable that the working length and wire being kinked, and the working length being ripped and torn happened by an excessive force being applied in the device.These problems could occur during its manipulation.Most likely procedural factors such as handling of the device, the technique used by the physician during initial use, set up, power up, or shortly thereafter could have affected its condition.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.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 small oval stiff snare was used to remove polyp in the descending colon during a polypectomy procedure performed on (b)(6), 2022.During the procedure and inside the patient, the snare loop was not able to remove the polyp.In addition, the plastic sheath was torn.The snare was securely attached to the active cord and no problems were noted with the cautery pin.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 stable.

• 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: 14349454
• MDR Text Key: 291371654
• Report Number: 3005099803-2022-02351
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0023891772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 65 KG