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

Model Number	M006L8406911
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same procedure.It was reported to boston scientific corporation on july 5, 2022 that a flexiva pulse id laser fiber was used during a lithotripsy procedure to treat stones in the bladder, performed on (b)(6) 2022.The laser unit used was a lumenis pulse 100 h laser console with laser settings of 0.6 joules, 6 hertz and 4 watts.On (b)(6) 2022, five days post procedure, the patient experienced cystitis.She was treated with cephalexin oral for infection and prochloreperazine iv for nausea and the patient's condition was resolved.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis of 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: 15103743
• Report Number: 3005099803-2022-04008
• Device Sequence Number: 19887120
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: 08714729978725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/26/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2024
• Device Model Number: M006L8406911
• Device Catalogue Number: 2130-02
• Device Lot Number: 0027916577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 88 KG