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 Code	Blood Loss (2597)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date - unknown due to unknown product code and lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown product code and lot number.The actual sample was not returned for evaluation.Therefore, the investigation was based on the evaluation of a current product sample of the involved product type.Visual inspection did not find any anomaly including a break in appearance.Magnified inspection did not find any anomaly that could lead to a fracture of the guide wire.The outer diameter was measured and confirmed to meet the manufacturer specification.Reproductive testing was previously performed and showed that the guidewire may become fractured depending on the force it is subjected to.The following are examples of those forces.A product sample was subjected to one-way pulling force until it became fractured.Subsequent electron microscopic inspection of the fracture revealed the outside diameter of the wire had been diminished toward the fracture end.A product sample was subjected to repetitive bending force at a 90-degree angle until it became fractured.Subsequent electron microscopic inspection of the fracture revealed that the fracture cross section had a dimple pattern.The fracture end had not been deformed in a curved shape.A product sample was subjected to repetitive one-way torque force until it became fractured.Subsequent electron microscopic inspection of the fracture revealed the generation of a radial pattern on the fracture surface.The fracture end was flat and straight.A product sample was subjected to pulling force in the state of being formed into a loop-like shape until it became fractured.Subsequent electron microscopic inspection of the fracture revealed the edge of the fracture was in the curved shape.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and shipping inspection record.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.It is likely that the actual sample was exposed to one of the forces described in the reproductive testing section, resulting in the reported fracture.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr (b)(4) for the importer report.(b)(4).
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 11mls.

• 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: 9483799
• Report Number: 9681834-2019-00212
• Device Sequence Number: 19426169
• Product Code: KOD
• UDI-Device Identifier: 04987350755575
• UDI-Public: 04987350755575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2019
• 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