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

Model Number M00535150

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; however, an analysis was performed based on a photo of the device that the complainant provided.The photo revealed that the cutting wire was observed sideways with the distal tip in the anatomy.However, it was not possible to determine if the catheter was correctly oriented.No other issues with the device were noted.The reported event of cutting wire orientation was confirmed.Upon analysis of the photo provided by the customer, the cutting wire was observed sideways, and it was not possible to observe if the catheter was correctly oriented.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Based on all gathered information, it was concluded that the most probable cause of this event is cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

Note: this report pertains to the first of three stonetome used during the same procedure.It was reported to boston scientific corporation that a stonetome was in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire orientation, with respect to the plastic tip, was incorrect.Additionally, the catheter tip orientation were incorrect when the device exited the scope.An additional two devices were used with the same event occurring.The procedure was completed with a jagtome 39.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10596882
• MDR Text Key: 208976569
• Report Number: 3005099803-2020-04188
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146667
• UDI-Public: 08714729146667
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 0025538414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• 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