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

Model Number M00535110

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a stonetome was used in the papilla during papillotomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.The procedure was completed with a second stonetome.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): problem code 3009 captures the reportable event of cutting wire orientation.Block h10: visual examination of the returned device revealed that the cutting wire was kinked and the working length distal section was twisted.The complaint was consistent with the reported event of wire orientation incorrect.It is possible that the factors encountered during the procedure, patient anatomy and/or the manner as the device was handled and manipualted could have caused the damages found in the device.Therefore, the most probable cause is adverse event related to procedure since the adverse event occured during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a stonetome was used in the papilla during papillotomy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.The procedure was completed with a second 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: 9503210
• MDR Text Key: 189843680
• Report Number: 3005099803-2019-06179
• 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: 02/13/2020

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: 06/04/2021
• Device Model Number: M00535110
• Device Catalogue Number: 3511
• Device Lot Number: 0023905208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/18/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1