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

Model Number	M006L8406961
Medical Device Problem Codes	Break (1069); Overheating of Device (1437); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device is retained and not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on may 16, 2022 that a flexiva pulse id laser fiber was used in a laser ureteroscopy procedure performed on (b)(6) 2022.The laser unit used was a versa pulse 100 laser console.During the procedure, the laser fiber broke in half.It burned a small hole in the patient's drape and wet towel.There was no burn injury to the user or to the patient.No fiber fragments fell inside the patient.The user confirmed the presence of the heat from the laser cable during the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on may 16, 2022 that a flexiva pulse id laser fiber was used in a laser ureteroscopy procedure performed on (b)(6) 2022.The laser unit used was a versa pulse 100 laser console.During the procedure, the laser fiber broke in half.It burned a small hole in the patient's drape and wet towel.There was no burn injury to the user or to the patient.No fiber fragments fell inside the patient.The user confirmed the presence of the heat from the laser cable during the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: block e4 and g3: medwatch number is mw5110024.Block h6: medical device code a0401 captures the reportable event of fiber break.Medical device code a0501 captures the reportable event of fiber overheats.Medical device problem code a050502 captures the reportable event of fiber misfire.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: the complainant indicated that the device is retained and not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 14620623
• Report Number: 3005099803-2022-03125
• Device Sequence Number: 17428171
• Product Code: GEX
• UDI-Device Identifier: 08714729978763
• UDI-Public: 08714729978763
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 01/26/2025
• Device Model Number: M006L8406961
• Device Catalogue Number: 2130-02
• Device Lot Number: 0028755471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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