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 Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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) 2018 that a flexiva 365 laser fiber was opened for use in a procedure performed on (b)(6) 2018.According to the complainant, during preparation, the tip of the laser fiber was noted to be cracked.The procedure was completed with another flexiva 365 laser fiber.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a follow-up report will be submitted.
Additional Manufacturer Narrative
Problem code 2976 captures the reportable event of fiber tip cracked.The fiber was returned broken in two pieces.The first piece measured approximately 45.7 cm from the connector to the break.The second piece measured approximately 228.9 cm from the break to the tip and includes the entire distal tip.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.Visual inspection of the returned fiber noted burn marks on the fiber jacketing, likely result of the fiber break occurring during resulting in a misfire.Visual inspection of the tip was also conducted, noting no issues with tip shape, size, or characteristics.Review and analysis of all available information indicated that the cause code for this event 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.
Event or Problem Description
It was reported to boston scientific corporation on october 10, 2018 that a flexiva 365 laser fiber was opened for use in a procedure performed on (b)(6) 2018.According to the complainant, during preparation, the tip of the laser fiber was noted to be cracked.The procedure was completed with another flexiva 365 laser fiber.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a follow-up report will be submitted.

• 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: 8039158
• Report Number: 3005099803-2018-61148
• Device Sequence Number: 1499498
• Product Code: GEX
• UDI-Device Identifier: 08714729808190
• UDI-Public: 08714729808190
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 08/25/2020
• Device Model Number: M0068403921
• Device Catalogue Number: 840-392
• Device Lot Number: 0000005012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1