MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STAINLESS STEEL GUIDEWIRE; INTRODUCER, CATHETER

Model Number	35655
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated based on the report of 1 month ago on (b)(6) 2018.
Event or Problem Description
It was reported that the wire broke and remained inside patient's body.An accustick stainless steel guidewire was selected for use.During the procedure, it was noted that the accustick guidewire broke off in the patient's body in the renalcalyx / retroperitoneum.The physician made attempts to retrieved the detached portion of the wire, however, failed.No further patient complications were reported and patient's condition post-procedure was okay.
Additional Manufacturer Narrative
Date of event: date of event was approximated based on the report of 1 month ago on (b)(6) 2018.
Event or Problem Description
It was reported that the wire broke and remained inside patient's body.An accustick stainless steel guidewire was selected for use.During the procedure, it was noted that the accustick guidewire broke off in the patient's body in the renalcalyx /retroperitoneum.The physician made attempts to retrieved the detached portion of the wire, however, failed.No further patient complications were reported and patient's condition post-procedure was okay.It was further reported approximately 1 cm of the guidewire remained in the body in the renal calyx / retro peritoneum.
Event or Problem Description
It was reported that the wire broke and remained inside patient's body.An accustick stainless steel guidewire was selected for use.During the procedure, it was noted that the accustick guidewire broke off in the patient's body in the renalcalyx / retroperitoneum.The physician made attempts to retrieved the detached portion of the wire, however, failed.No further patient complications were reported and patient's condition post-procedure was okay.It was further reported approximately 1 cm of the guidewire remained in the body in the renal calyx / retro peritoneum.It was further reported, via medwatch mw5080195, that during a left percutaneous nephrostomy tube placement, for left hydronephrosis toroidal left ureter secondary to obstructing stone, 1cm of a 018 guidewire fragment lodged partially in the renal cortex and retroperitoneum.During the procedure, it was noted that the retained wire could not be seen anywhere in the tract or in the renal pelvis or any of the calyces.

• Brand Name: STAINLESS STEEL GUIDEWIRE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7853207
• Report Number: 2134265-2018-60567
• Device Sequence Number: 2469219
• Product Code: DYB
• UDI-Device Identifier: 08714729115533
• UDI-Public: 08714729115533
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K952828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2021
• Device Model Number: 35655
• Device Catalogue Number: 35655
• Device Lot Number: 0022310004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/16/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/01/2018; 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention