MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE UROLOGIC WIRE; CATHETER, UROLOGICAL

Model Number	RF*PS35153U
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per fda medwatch report # mw5090191.The event description states: "a female with a history of right flank pain due to right ureteropelvic junction obstruction.The patient scheduled for elective robotic right pyeloplasty secondary to right ureteropelvic junction obstruction.Prior to the end of the surgical case, a fluoroscopic guidance kub was completed.Two static images of the abdomen/ pelvis were archived at the end of the procedure prior to the pt leaving the operating room.The pt's intra-op static images showed a "thin, short linear density projected over the right lower quadrant of the abdomen" and could not rule out the possibility of a foreign body.For pt safety purposes, images were submitted for radiologist review and evaluated for unexpected findings.The surgeon was notified of results and ordered a repeat kub which showed a "foreign body in the pt's lower quadrant on the right side." the surgeon ordered a ct scan without contrast that confirmed the presence of a foreign body adjacent to the colon on the right side.The findings were relayed to surgeon as a critical finding.The pt returned to surgery on for a laparoscopy and removal of the foreign body.Fda safety report id#.(b)(4)".Additional information was received on 19nov2019.The patient was reported to be in stable condition.The surgical intervention was a success.There was an estimated blood loss of 11 mls.

• Brand Name: RADIFOCUS GLIDEWIRE UROLOGIC WIRE
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9483784
• Report Number: 2243441-2019-00122
• Device Sequence Number: 3541975
• Product Code: KOD
• UDI-Device Identifier: 04987350755575
• UDI-Public: 04987350755575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/17/2019
• Report Date (Section F): 12/17/2019

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 Model Number: RF*PS35153U
• Device Catalogue Number: UWS1035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• 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
• Patient Age: 10 YR
• Patient Weight: 34
• Date Report Sent to FDA: 12/17/2019