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	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).(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
Note: this manufacturer report pertains to one of three flexiva laser fibers that were used in the same procedure.It was reported to boston scientific corporation on september 14, 2018 that three flexiva laser fibers [flexiva id 365, flexiva id tractip 200 and flexiva id 200] were used in a ureteroscopy with laser lithotripsy procedure in the right kidney performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that a flexiva id tractip 200 laser fiber and a flexiva id 200 laser fiber were broken before it was use on the patient.A flexiva id 365 was used and it was broken inside the lithovue disposable ureteroscope.A broken fragment fell inside the kidney.A new flexible lithovue ureteroscope was opened and the broken piece was retrieved by basket extraction from the right kidney.The procedure was completed.There were no complications reported as a result of this event.
Additional Manufacturer Narrative
Block e4: this event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).Block h6: problem code 1069 captures the reportable event of fiber broke.Block h10: investigation results: the fiber was returned broken into two pieces.The first piece measured approximately 278.0 cm from the top of the connector to the break.The second piece measured approximately 1.9 cm from the break including the distal tip.The exposed glass tip showed signs of slight degradation.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.
Event or Problem Description
Note: this manufacturer report pertains to one of three flexiva laser fibers that were used in the same procedure.It was reported to boston scientific corporation on september 14, 2018 that three flexiva laser fibers [flexiva id 365, flexiva id tractip 200 and flexiva id 200] were used in a ureteroscopy with laser lithotripsy procedure in the right kidney performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that a flexiva id tractip 200 laser fiber and a flexiva id 200 laser fiber were broken before it was use on the patient.A flexiva id 365 was used and it was broken inside the lithovue disposable ureteroscope.A broken fragment fell inside the kidney.A new flexible lithovue ureteroscope was opened and the broken piece was retrieved by basket extraction from the right kidney.The procedure was completed.There were no complications reported as a result of this event.

• Brand Name: FLEXIVA (TM) ID 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: 7961301
• Report Number: 3005099803-2018-60814
• Device Sequence Number: 19146227
• Product Code: GEX
• UDI-Device Identifier: 08714729963783
• UDI-Public: 08714729963783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 07/02/2021
• Device Model Number: M006R8403921
• Device Catalogue Number: 69271
• Device Lot Number: 0000006265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 79