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	Septic Shock (2068)
Date of Event	05/01/2016
Type of Reportable Event	Serious Injury
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 e233605 captures the reportable event of septic shock.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f0801 captures the reportable event of intensive care.
Event or Problem Description
Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced septic shock and was admitted to the intensive care unit (icu) and treated with intravenous (iv) antibiotics.In the physician's assessment the event was not related to the imager ii, percutaneous access needle and 8/10 dilator sheath set but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax but was causally related to the procedure.

• 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: 16714589
• Report Number: 3005099803-2023-01859
• Device Sequence Number: 20648898
• 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
• Report Date (Section B): 04/11/2023

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): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/11/2023
• 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; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic