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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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) 2018 that a flexiva 1000 laser fiber was opened for use in a ureteroscopy with lithotripsy procedure in the kidney performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the laser fiber was noted to be broken in half upon removal from the package.The procedure was completed with another flexiva 1000 laser fiber.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: 7453838
• Report Number: 3005099803-2018-01217
• Device Sequence Number: 16383573
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/02/2018

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: 08/24/2020
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000005007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR