MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY

Model Number M00535150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 stonetome was used in a procedure performed on an unknown date.According to the complainant, during the procedure, when the device was energize the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with another of same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: the returned stonetome was analyzed, and a visual evaluation noted that the cutting wire was detached, bent and blackened.Also, the working length was observed bent at 85cm from the distal tip.Additionally, under magnification inspection the cut surface of the cutting wire was observed to be not smooth.A functional evaluation could not be performed due to the condition of the device.No other issues with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, the cutting wire was found detached, bent and blackened.The cutting wire being blackened indicates that the device was energized.Additionally, the working length was bent in the distal section.Based on the condition of the device, the failure found could had been generated if the device was not completely in contact with the tissue when it was energized.This could be due to the bend in the working length.Also, if there was contact between the device and the endoscope.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a stonetome was used in a procedure performed on an unknown date.According to the complainant, during the procedure, when the device was energize the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with another of same device.There were no patient complications reported as a result of this event.

• Brand Name: STONETOME
• Type of Device: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10483605
• MDR Text Key: 209803097
• Report Number: 3005099803-2020-03678
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: 08714729146667
• Combination Product (y/n): N
• PMA/PMN Number: K946358
• 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: 10/07/2020

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: 10/15/2021
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0024608514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/09/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/07/2020
• Patient Sequence Number: 1