MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403930
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.(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) 2021 that a flexiva 550 laser fiber was used in a cystolithotripsy procedure in the bladder performed on (b)(6) 2021.During the procedure, the laser fiber was broken inside the scope.No fiber fragments fell inside the patient.The procedure was not completed due to unrelated reasons.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0401 captures the reportable event of fiber break.Block h10: investigation results: the returned flexiva 550 laser fiber was analyzed, and a visual evaluation noted that it was returned in two pieces.The piece measured approximately 248.5 cm from the top of the connector to the fiber break and 30.5 cm from the exposed glass tip to the fiber break.In addition, the exposed glass tip measures 5 mm and appeared in good condition.The light from the sma connector was bright and clear.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that it was fractured along the fiber body.The fiber can interact with the scope as it passes through, which in tortuous anatomy can cause stresses that can result in fiber damage.Articulation of the scope with a fiber extended through the scope may also cause stresses to the fiber to cause damage.It is likely the interaction with the scope as the device was handled in the procedure contributed to the event.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing a labeling review was performed and, from the information available, this device was used per the directions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a flexiva 550 laser fiber was used in a cystolithotripsy procedure in the bladder performed on (b)(6) 2021.During the procedure, the laser fiber was broken inside the scope.No fiber fragments fell inside the patient.The procedure was not completed due to unrelated reasons.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12049357
• Report Number: 3005099803-2021-02948
• Device Sequence Number: 14560083
• Product Code: GEX
• UDI-Device Identifier: 08714729808206
• UDI-Public: 08714729808206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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 Model Number: M0068403930
• Device Catalogue Number: 840-393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1