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	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Mfg site name-coherent inc.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)(4) 2017 that a flexiva 1000 laser fiber was used during a bladder stone litholapaxy procedure in the bladder performed on (b)(6) 2017.Reportedly, the laser unit used was holmium 100 watt laser console with settings of 1 joule and 50 herrtz.The total energy used was 50 watts.According to the complainant, during the procedure and inside the patient, when the physician hit the pedal to fire laser energy at the stone, the fiber tip broke off.There were no fiber fragments observed inside the patient and nothing was retrieved.The procedure was completed with another 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.
Additional Manufacturer Narrative
One flexiva 1000 laser fiber was received for evaluation.Visual examination revealed that there was no exposed glass fiber tip remaining.Additional examination under magnification revealed that the pattern on the tip face was consistent with a fracture indicating that the tip or portion of the tip broke off.The condition of the returned device confirms the event.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a flexiva 1000 laser fiber was used during a bladder stone litholapaxy procedure in the bladder performed on (b)(6) 2017.Reportedly, the laser unit used was holmium 100 watt laser console with settings of 1 joule and 50 herrtz.The total energy used was 50 watts.According to the complainant, during the procedure and inside the patient, when the physician hit the pedal to fire laser energy at the stone, the fiber tip broke off.There were no fiber fragments observed inside the patient and nothing was retrieved.The procedure was completed with another 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: 7097446
• Report Number: 3005099803-2017-03639
• Device Sequence Number: 13797657
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 11/17/2017

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: 10/05/2020
• Device Model Number: M0068403940
• Device Catalogue Number: 840-394
• Device Lot Number: 0000005158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR