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

Model Number	M0068403941
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional 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 medwatch will be filed.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2020-03681 for the first flexiva 1000 laser fiber and mfr.Report # 3005099803-2020-03682 for the second flexiva 1000 laser fiber.It was reported to boston scientific corporation on (b)(6) 2020 that a flexiva 1000 laser fiber was used in a bladder stone procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the fiber tip broke off inside the patient.A second of the same device was opened and the same issue occurred.Reportedly, the fiber tips were retrieved successfully with a grasper.The procedure was completed with a third flexiva 1000 laser fiber.There were no patient complications reported as a result of this event.

• 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: 10482984
• Report Number: 3005099803-2020-03681
• Device Sequence Number: 3860224
• Product Code: GEX
• UDI-Device Identifier: 08714729808138
• UDI-Public: 08714729808138
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: M0068403941
• Device Catalogue Number: 840-394
• Device Lot Number: 0000009398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention