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

Model Number	M006R8403921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental medwatch report will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva id 365 laser fiber was opened for use in a cystoscopy ureteral stone extraction with laser procedure in the ureter performed on (b)(6) 2018.According to the complainant, during the procedure, the fiber was noted to be broken and approximately 2 inches was stuck in the ureteroscope.The procedure was completed with another scope and flexiva id 365 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.There were no patient complications noted.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva id 365 laser fiber was opened for use in a cystoscopy ureteral stone extraction with laser procedure in the ureter performed on (b)(6) 2018.According to the complainant, during the procedure, the fiber was noted to be broken and approximately 2 inches was stuck in the ureteroscope.The procedure was completed with another scope and flexiva id 365 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.There were no patient complications noted.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of fiber broke.Investigation results: the fiber was returned broken into two pieces.The first piece measured approximately 5.5 cm from the top of the connector to the break.The second piece measured approximately 267.3 cm which includes the entire distal tip.The condition of the returned device confirmed that the fiber was broken.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.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.

• Brand Name: FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8107926
• Report Number: 3005099803-2018-61533
• Device Sequence Number: 11253169
• Product Code: GEX
• UDI-Device Identifier: 08714729963783
• UDI-Public: 08714729963783
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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: 06/05/2021
• Device Model Number: M006R8403921
• Device Catalogue Number: 69271
• Device Lot Number: 0000006130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1