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

Model Number M00535110

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

(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 during a stone removal procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with another stonetome.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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.It was noted under magnification that the cut in the cutting wire was not smooth showing it was not a mechanical cut.The reported event was confirmed.The failure found could had been generated if the cutting wire is not completely in contact with the tissue when applying electrocautery current or if there was contact between the endoscope and the cutting wire while electrical current is applied.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 the device met all manufacturing specifications.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 during a stone removal procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with another stonetome.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: 10436976
• MDR Text Key: 204046156
• Report Number: 3005099803-2020-03459
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: 08714729146599
• 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: 09/16/2020

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: 03/02/2022
• Device Model Number: M00535110
• Device Catalogue Number: 3511
• Device Lot Number: 0025290218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1