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 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.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 an endoscopic sphincterotomy (est) procedure.According to the complainant, during procedure, it was noticed that the cut wire was oriented in the wrong direction.The procedure was completed with a second stonetome.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Visual examination of the returned device revealed that the working length was twisted at the distal section.There was no other issue noted.The complaint was consistent with the reported event of incorrect orientation which could have been affected by the twisted working length.The working length twisted is a known caused during manipulation of the device or due to the interaction with the endoscope or with other devices, the most probable cause of this complaint is adverse event related to procedure, the adverse event occurred 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 an endoscopic sphincterotomy (est) procedure.According to the complainant, during procedure, it was noticed that the cut wire was oriented in the wrong direction.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: 8430561
• MDR Text Key: 139165315
• Report Number: 3005099803-2019-01227
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: M00535150
• Device Catalogue Number: 3515
• Device Lot Number: 22593007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1