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 Codes	Sepsis (2067); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study: (b)(6) clinical trial.(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 a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexiva pulse laser fiber was used during a lithotripsy procedure of the upper pole of the right kidney, performed on (b)(6) 2021, as part of the u0703 flexiva pulse registry clinical trial.The procedure was completed with the flexiva pulse laser fiber.Prior to discharge, the patient experienced sepsis that was probably related to the flexiva pulse laser fiber and had a causal relationship to the lithotripsy procedure.The sepsis was considered life threatening, additional intervention was required and the patient was hospitalized and catheterized.The sepsis was treated with medication: maxipime, normal saline, vancocin, tylenol, amikin, trimpex, benadryl, toradol, zofran, levaquin, ephedrine, ceftin.The patient was hospitalized from (b)(6) 2021, the patient was catheterized from (b)(6) 2021, and the sepsis was resolved.On (b)(6) 2021, the patient experienced bladder spasms that was non-serious, possibly related to the flexiva pulse laser fiber and probably related to the lithotripsy procedure.The bladder spasms were treated with medication: toviaz, glycopyrrolate/neostigmine, toradol, pyridium, ditropan.The bladder spasms issue is ongoing and not yet resolved.
Additional Manufacturer Narrative
Block b5: description of event or problem update based on additional information received on january 11, 2022.Block b7: other relevant medical history updated based on the additional information received january 10, 2022.Block g2: study: u0703 flexiva pulse registry clinical trial block h6: patient code e0306 captures the reportable event of sepsis.Block h10: the flexiva pulse laser fiber was not returned for evaluation.A labeling review was performed and the reported patient effect of "infection" is listed in the flexiva pulse id laser fiber ifu as a potential outcome of the procedure.A medical review was performed, and the event of urinary tract infection resulting in sepsis is anticipated in nature per the flexiva pulse id laser fiber ifu.Based on all of the available information, the complaint is assigned a probable cause of known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a flexiva pulse laser fiber was used during a lithotripsy procedure of the upper pole of the right kidney, performed on (b)(6)., 2021, as part of the u0703 flexiva pulse registry clinical trial.The procedure was completed with the flexiva pulse laser fiber.Prior to discharge, the patient experienced sepsis that was probably related to the flexiva pulse lase fiber and had a casual relationship to the lithotripsy procedure.The sepsis was considered life threatening, additional intervention was required and the patient was hospitalized, catheterized, and given medication to treat the sepsis.The medication given was maxipime, normal saline, vancocin, tylenol, amikin, trimpex, benadryl, toradol, zofran, levaquin, ephedrine, ceftin.The patient was hospitalized from (b)(6) 2021 through (b)(6) 2021, the patient was catheterized from (b)(6) 2021 through (b)(6) 2021, and the sepsis was resolved.On (b)(6) 2021, the patient experienced bladder spasms that was non-serious, possibly related to the flexiva pulse laser fiber and probably related to the lithotripsy procedure.The bladder spasms were treated with medication: toviaz, glycopyrrolate/neostigmine, toradol, pyridium, ditropan.The bladder spasms issue is ongoing and not yet resolved.Additional information received january 11, 2022.The clinical site confirmed that the bladder spasms were not related to either the flexiva pulse laser fiber or the lithotripsy procedure.

• 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: 13191005
• Report Number: 3005099803-2021-08032
• Device Sequence Number: 5935248
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: 08714729978725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 03/24/2024
• Device Model Number: M006L8406911
• Device Catalogue Number: 2130-02
• Device Lot Number: 0027030926
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 102 KG