MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II UROLOGY TORQUEABLE CATHETER; CATHETER, UROLOGICAL

Model Number	M0064003001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	05/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii and percutaneous access needle were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced sepsis.In the physician's assessment the event was probably related to the imager ii and percutaneous access needle but the relationship to the procedure was not reported.
Additional Manufacturer Narrative
Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0306 captures the reportable event of sepsis.
Event or Problem Description
Note: this report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii and percutaneous access needle were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced sepsis.In the physician's assessment the event was probably related to the imager ii and percutaneous access needle but the relationship to the procedure was not reported.Additional information received on april 3, 2023: it was reported that the patient was given antibiotics for sepsis.In the physician's assessment the event was probably related to the imager ii and percutaneous access needle but was causally related to the procedure.
Additional Manufacturer Narrative
Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient code e0306 captures the reportable event of sepsis.Imdrf impact code f2303 captures the reportable event of medication required.

• Brand Name: IMAGER II UROLOGY TORQUEABLE CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TELEFLEX MEDICAL (TFX); units 7, 8 & 9; annacotty business park; annacotty, county limerick ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16712495
• Report Number: 3005099803-2023-01936
• Device Sequence Number: 1609501
• Product Code: KOD
• UDI-Device Identifier: 08714729430261
• UDI-Public: 08714729430261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102527
• 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): 05/02/2023

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: M0064003001
• Device Catalogue Number: 400-300
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/02/2023
• 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: 63 YR
• Patient Sex: Female
• Patient Race: White