MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that an accutrac 200 laser fiber was used in a ureteroscopy with laser lithotripsy procedure in the ureter performed on (b)(6) 2020.Reportedly, the laser unit used was a dornier 20 watt laser console with laser settings of 1500 millijoules and 10 hertz.According to the complainant, during the procedure, the laser fiber broke about 6 to 7 inches from the proximal tip inside the scope.Reportedly, no fiber fragments fell inside the patient.The fragment was inside the scope when removed from the patient's body.The procedure was completed with another accutrac 200 laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1069 captures the reportable event of fiber break.Block h10: the reported accutrac 200 laser fiber was received for analysis.The fiber measured approximately 308 cm from the top of the connector to the break.The remainder of the fiber, including the distal tip, was not returned.Examination under magnification confirms the pattern on the tip is consistent with a fracture.Light from the sma connector was bright, round, and clear.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the glass tip end of the laser fiber was separated and not returned.The condition of the returned device confirms that the fiber was broken during use, likely as a result of handling of the device as it was used and interacted with the scope.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 that an accutrac 200 laser fiber was used in a ureteroscopy with laser lithotripsy procedure in the ureter performed on (b)(6), 2020.Reportedly, the laser unit used was a dornier 20 watt laser console with laser settings of 1500 millijoules and 10 hertz.According to the complainant, during the procedure, the laser fiber broke about 6 to 7 inches from the proximal tip inside the scope.Reportedly, no fiber fragments fell inside the patient.The fragment was inside the scope when removed from the patient's body.The procedure was completed with another accutrac 200 laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10340029
• Report Number: 3005099803-2020-03041
• Device Sequence Number: 11627659
• Product Code: GEX
• UDI-Device Identifier: 08714729802709
• UDI-Public: 08714729802709
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K110686
• 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): 09/22/2020

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: 03/18/2023
• Device Model Number: M0068404112
• Device Catalogue Number: 840-411
• Device Lot Number: 0000009311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1