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

Model Number M00562301

Device Problems Retraction Problem (1536); Failure to Cut (2587)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used for polyp removal in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when the physician took out the device, it was found that the handle was not tight enough and snare loop failed to retract to cut the polyp completely.This caused the specimen to burn for a long time and finally the specimen was damaged and could not be tested.The procedure was completed with another captivator snare.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

(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.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used for polyp removal in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when the physician took out the device, it was found that the handle was not tight enough and snare loop failed to retract to cut the polyp completely.This caused the specimen to burn for a long time and finally the specimen was damaged and could not be tested.The procedure was completed with another captivator snare.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

Block h6: problem code a050702 captures the reportable event of snare loop unable to cut.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 (strain relief) and wire were kinked.Functional inspection was performed and the device contracted and extended well even with the kink found.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The investigation concluded that the observed kink in the working length and wire was likely due to an excessive force being applied over the device by the anatomy or the normal interaction of the device with the scope.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 the device and led to the working length and wire being kinked.Additionally, the impact code of "inadequate/inappropriate treatment or diagnostic exposure" could be the result of the use of the device when the working length (strain relief) was kinked.If the device could extend and retract however the condition of the device made more friction between the drive wire and sheath, the specimen could be damaged and not be able to be tested.The reported event of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of loop retraction problem was unable to be confirmed since the device extended and retracted well upon return.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 problem, design or user problem which could have caused the complaint.Device analysis could not confirm the reported events.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.

• 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: 13051453
• MDR Text Key: 282551618
• Report Number: 3005099803-2021-07736
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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: 07/08/2022
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0024080068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 74 KG