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

Model Number	M0068403921
Medical Device Problem Codes	Break (1069); Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A flexiva 365 laser fiber was returned in one continuous piece.The returned piece measured approximately 277.8 cm from the top of the connector to the tip which includes the complete distal tip.There was no damage along the body of the fiber.The investigator was unable to examine the fiber face within the sub miniature-a (sma) connector because light was unable to travel to the fiber face, this indicated that the fiber was broken within the connector.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 device history record (dhr) was performed; no anomalies were noted.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva 365 laser fiber was used during a ureteroscopy, laser lithotripsy procedure in the ureter performed on (b)(6) 2018.Reportedly, the laser unit used was a holmium console.According to the complainant, during the procedure, it was noted that there was no laser energy coming out from the laser fiber.The procedure was completed with another flexiva 365 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the laser fiber was broken within the sma connector.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE 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: 8214766
• Report Number: 3005099803-2018-62322
• Device Sequence Number: 1987873
• Product Code: GEX
• UDI-Device Identifier: 08714729808190
• UDI-Public: 08714729808190
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• 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
• Report Date (Section B): 01/03/2019

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: 05/22/2021
• Device Model Number: M0068403921
• Device Catalogue Number: 69146
• Device Lot Number: 0000006072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1