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

Model Number M00535190

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

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 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
• Type of Device: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8519485
• MDR Text Key: 142128959
• Report Number: 3005099803-2019-01955
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 08714729146612
• UDI-Public: 08714729146612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1