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

Model Number	M0068403940
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	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been 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 manufacturer report pertains to the one of three devices used in the same procedure.Refer to the associated manufacturer report numbers: 3005099803-2018-01669, 3005099803-2018-01670 and 3005099803-2018-01671 for the referenced device information.It was reported to boston scientific corporation on (b)(6) 2018 that three flexiva 1000 laser fibers were used in a cystoscopy with laser lithotripsy procedure in the bladder performed on (b)(6) 2018.Reportedly, the laser unit used was a lumenis versapulse 100 watt console.According to the complainant, during the procedure and inside the patient, the first fiber was used for 10 minutes and the tip broke off (captured in mfr.Report number 3005099803-2018-01669).Another fiber was used and after 5 minutes, the tip also broke off (captured in mfr.Report number 3005099803-2018-01670).A third fiber was then used and after 2 minutes, the tip also broke off (captured in mfr.Report number 3005099803-2018-01671).Reportedly, the fiber fragments that fell inside the patient were flushed out.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7553937
• Report Number: 3005099803-2018-01669
• Device Sequence Number: 1187304
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/09/2018

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: 03/30/2021
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000005831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1