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

Model Number	2130-02
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 june 30, 2022 that a flexiva pulse id laser fiber was used during a procedure, performed on (b)(6) 2022.During the procedure, the laser fiber produced smoke when it was attached into the laser console.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation on june 30, 2022 that a flexiva pulse id laser fiber was used during a procedure, performed on (b)(6) 2022.During the procedure, the laser fiber produced smoke when it was attached into the laser console.There were no patient complications reported as a result of this event.**additional information received on july 26, 2022** it was reported to boston scientific corporation on june 30, 2022, that a flexiva pulse id laser fiber was used during a holmium laser ablation procedure to treat stones in the bladder, ureter, and kidney, performed on (b)(6) 2022.The laser unit used was a lumenis pulse 100 watt laser console with laser settings of 0.3 joules and 53 hertz.During the procedure, the fiber connector was warm to the touch and smoke was observed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: block b5 and block e: initial reporter updated based on the additional information received on july 26, 2022.Block h6: medical device problem code a1005 captures the reportable event of fiber connector overheats.Block h10: 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 june 30, 2022 that a flexiva pulse id laser fiber was used during a procedure, performed on (b)(6) 2022.During the procedure, the laser fiber produced smoke when it was attached into the laser console.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Upon receipt, this product was thoroughly analyzed in our quality assurance laboratory.Visual analysis of the returned fiber confirmed the reported smoke produced by the fiber event as analysis identified a fracture within the connector.During functional testing, there was no light present from the sub miniature a (sma) connector, indicating a fracture within the connector.The fiber connector may have a developed a microfracture that with use or handling can become larger resulting in an insufficient aiming beam and low laser energy output and ultimately can lead the connector to become overheated.According to the device instructions for use.Do not bend fiber at sharp angles.Visible light seen leaking from the fiber indicates fiber damage.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15103269
• Report Number: 3005099803-2022-03917
• Device Sequence Number: 4588060
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: 08714729978725
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2022

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: 01/03/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0028618561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 10/04/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/09/2022; 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown