MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TERUMO RADIO FOCUS GLIDEWIRE; GLIDEWIRE CATHETER

Lot Number	170725
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the glide wire coating fractured, unable to advance catheter so wire was removed.Fracture noted to coating.New wire was used.No adverse effects noted.All pieces of coating accounted for after procedure.No pt harm noted.

• Brand Name: TERUMO RADIO FOCUS GLIDEWIRE
• Common Device Name: GLIDEWIRE CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; somerset NJ 08873
• MDR Report Key: 7049126
• Report Number: MW5073474
• Device Sequence Number: 1211477
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: 0104987350773159
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Lot Number: 170725
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2017
• 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: Other
• Patient Age: 56 YR
• Patient Weight: 69