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

Model Number M00535170

Device Problem Positioning Problem (3009)

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

Event Date 06/22/2021

Event Type  malfunction  

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 stonetome was used in the papilla during a papillotomy procedure performed on (b)(6) 2021.During procedure, it was noticed that the "direction of the blade" of the stonetome was incorrect.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned stonetome was analyzed, and a visual evaluation noted that the working length was twisted at the distal section which was consistent to the findings when the device was observed under magnification.Also, marks were observed over the extrusion at distal section indicating it was rubbed against a hard surface.A functional evaluation noted that the distal tip of the device, when exiting the endoscope, was twisted and facing to the side of the scope.No other problems with the device were noted.Upon analysis, it was found that the working length was twisted, which caused the distal tip of the device facing to the side of the scope.Based on the condition of the device, the problem found could have been caused due to manipulation of the device, the interaction with the endoscope, rotating the device while the tip is not completely out of the scope, or rotating the device to get a better orientation.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.

Event Description

It was reported to boston scientific corporation that a stonetome was used in the papilla during a papillotomy procedure performed on (b)(6) 2021.During procedure, it was noticed that the "direction of the blade" of the stonetome was incorrect.The procedure was completed with another of the 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: 12136177
• MDR Text Key: 260835712
• Report Number: 3005099803-2021-03355
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146629
• UDI-Public: 08714729146629
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: M00535170
• Device Catalogue Number: 3517
• Device Lot Number: 0027015598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1