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 device has not been received for analysis.Upon receipt and 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 or Problem Description
Note: this report pertains to the first 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.
Event or Problem Description
Note: this report pertains to the first 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.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 3009 captures the reportable event of positioning problem.Block h10: visual analysis of the returned device found in good conditions and without any visual damage.Functionally, the device was bowed and it was bowed more than 90 degrees and within specifications.Based on all compiled information on this investigation, the most probable cause is no problem detected since the complaint included a returned device review which showed no evidence of either the alleged issue or any defect which could have contributed to the 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.Block h11: correction to block h4.

• 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: 8519418
• Report Number: 3005099803-2019-01954
• Device Sequence Number: 13915029
• 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,Followup
• Report Date (Section B): 07/09/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1