MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DUAL LUMEN URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064051000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Urinary Tract Infection (2120)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Study: u0703 flexiva pulse registry clinical trial.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to a boston scientific ureteral catheter used with a boston scientific fiber and basket in the same patient and procedure.It was reported to boston scientific corporation that the patient was enrolled into the u0703 flexiva pulse registry study on (b)(6) 2022.On (b)(6) 2022, the patient underwent a lithotripsy procedure for stone management using a flexiva pulse laser fibers, a zero tip basket, and a dual lumen ureteral catheter in the left kidney.During the procedure, the devices were introduced into the patient without problems and the procedure was completed without patient complications.On (b)(6) 2022, the patient experienced symptoms of inflammation (pyelitis) and infection (cystitis) with non serious severity.The patient was given a percocet 5-325mg for the pyelitis and a cephalexin 500mg for the cystitis.The pyelitis was considered resolved on (b)(6) 2022 and the cystitis was considered resolved on (b)(6) 2022.In the physicians assessment, there is no relationship between the adverse event and the dual lumen ureteral catheter and a probable relationship between the adverse event and the lithotripsy procedure.There was no reported malfunction or deficiency of the dual lumen ureteral catheter.No further information has been obtained despite good faith efforts.

• Brand Name: DUAL LUMEN URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15242485
• Report Number: 3005099803-2022-04495
• Device Sequence Number: 4655274
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: 08714729012689
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K860337
• 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
• Report Date (Section B): 08/17/2022

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 Model Number: M0064051000
• Device Catalogue Number: 405-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 64 KG