MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) 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	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Device code relates to problem code for the reported event of cutting wire incorrect orientation.Visual examination of the returned device found that the cutting wire bent/kinked and the working length twisted in multiple locations.No other issue was noted.The complaint was consistent with the reported event of incorrect orientation which could have been affected by twisted working length in multiple locations and bent/kinked cutting wire.Based on the investigation and the receipt condition/functionality, the complaint conclusion investigation code selected for this complaint is "operational context¿ since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, the performance of the device was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome¿ was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the 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¿
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7281782
• Report Number: 3005099803-2018-00434
• Device Sequence Number: 10796970
• Product Code: LQR
• UDI-Device Identifier: 08714729146612
• UDI-Public: 08714729146612
• Combination Product (Y/N): N
• PMA/510(K) Number: K946358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: 07/17/2019
• Device Model Number: M00535190
• Device Catalogue Number: 3519
• Device Lot Number: 20895715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1