MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) STONETOME¿; DISLODGER, STONE, BILIARY

Model Number	M00535190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported to boston scientific corporation that a stonetome¿ was about to be used in a procedure on (b)(6) 2018.According to the complainant, during unpacking outside the patient, it was noticed that the edge of cutting wire broke off.Reportedly, the device was handled lightly when it was unpacked.The procedure was completed with a second stonetome¿.There were no patient complications reported for this event.
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was about to be used in a procedure on (b)(6) 2018.According to the complainant, during unpacking outside the patient, it was noticed that the edge of cutting wire broke off.Reportedly, the device was handled lightly when it was unpacked.The procedure was completed with a second stonetome.There were no patient complications reported for this event.
Additional Manufacturer Narrative
Visual examination of the returned device found that the cutting wire was broken and blackened (has evidence of evidence of electricity or current was applied).No other issue was noted.The complaint was consistent with the reported event of broken cutting wire.It is most likely that a peak of voltage could have caused the failures noted.Additionally, during manufacturing process the units are inspected in order to avoid or detect defects, however, there is no control in how devices are manipulated in the field.Based on all the available information and the condition of the returned device, the most probable cause of this complaint will be documented as ¿operational context¿.A dhr (device history record) review was performed and no deviation was found.

• 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: 7736713
• Report Number: 3005099803-2018-02446
• Device Sequence Number: 805444
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 12/01/2019
• Device Model Number: M00535190
• Device Catalogue Number: 3519
• Device Lot Number: 0021460061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1