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

Model Number	RF*PS38153U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional - requested, not provided.Occupation - requested, not provided.(b)(4).The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the shipping inspection record of the product code/lot# combination was conducted with no findings.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 9681834-2019-00057.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported that the doctor was using two radifocus glidewire urologic wires, and they broke in the patient.The broken part was recovered.There was no patient injury or fatality.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in and to provide the completed investigation results.The actual device was not returned to the manufacturing facility for evaluation.However, 5 unused samples from the involved product code/lot# combination were returned for evaluation.The sample was unpacked carefully, and visual inspection revealed that there were no anomalies.Magnifying inspection confirmed the sample did not have any anomaly, such as a scratch, which would relate to an occurrence of a fracture of the shaft along the total length of the device.The outside diameter was measured and verified to meet the specifications.The tensile strength of the distal section was determined and verified to meet the specifications.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the unused samples.The investigation result verified that the returned samples were the normal products without any anomaly which would relate to an occurrence of a fracture on the shaft.Based on the investigation results, it is likely that the actual sample was subjected to some force and the core wire was fractured and the urethane outer layer was ripped off by subsequent force.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GLIDEWIRE UROLOGIC WIRE
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8527375
• Report Number: 9681834-2019-00056
• Device Sequence Number: 1871137
• Product Code: KOD
• UDI-Device Identifier: 04987350755650
• UDI-Public: 04987350755650
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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 Expiration Date: 05/31/2020
• Device Model Number: RF*PS38153U
• Device Catalogue Number: UWS1038
• Device Lot Number: 180629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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