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	Confusion/ Disorientation (2553)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2019.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Adverse event problem: imdrf patient code e010701 captures the reportable event of delirium.Imdrf impact code f08 captures the reportable event of readmission.
Event or Problem Description
Note: this report pertains to one of three devices used in the same patient and procedure.It was reported to boston scientific corporation that an imager ii, 8/10 dilator sheath set and percutaneous access needle were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2019.The patient experienced delirium and was readmitted.In the physician's assessment the event was not related to the imager ii and 8/10 dilator sheath set but was probably related to the procedure.In the physician's assessment the event was possibly related to the percutaneous access needle but was probably 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 july 2019.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on april 3, 2023.Block h6: imdrf patient code e010701 captures the reportable event of delirium.Imdrf impact code f08 captures the reportable event of readmission.
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 8/10 dilator sheath set were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6)2019.The patient experienced delirium and was readmitted.In the physician's assessment the event was not related to the imager ii and 8/10 dilator sheath set but was probably related to the procedure.Additional information received on april 3, 2023: it was clarified that a percutaneous access needle was not used in 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: 16709990
• Report Number: 3005099803-2023-01834
• Device Sequence Number: 5921297
• 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): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/10/2023
• 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: Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White