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

Model Number	M00535190
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental report will be filed.
Event or Problem Description
Note: this report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the nurse attempted to bow the device, it was noticed that the cut wire was oriented in the wrong direction which was reportedly pointing at 6 o'clock direction.It remained unusable as the orientation could not be corrected.A second stonetome was used but same thing happened.Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the devices prior to putting it through the scope or after the issue occurred.The procedure was completed with the different device.There were no patient complications reported as a result of this event.

• Brand Name: STONETOME
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8519485
• Report Number: 3005099803-2019-01955
• Device Sequence Number: 19151948
• Product Code: LQR
• UDI-Device Identifier: 08714729146612
• UDI-Public: 08714729146612
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K946358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2020
• Device Model Number: M00535190
• Device Catalogue Number: 3519
• Device Lot Number: 0022349247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1