MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA UNK GLIDEWIRE; WIRE, GUIDE, CATHETER

Lot Number	200109
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported the involved glide wire 035 260 angled fractured while removing.A voluntary medwatch was provided by (b)(4) hospital on (b)(6) 2020.The event description states: "during removal of an inferior vena cava filter a tiny fragment of the guidewire was sheared from the wire." additional information was received on 31jul2020.The device fractured inside the patient; a very small piece sheared off inside the patient.The piece was very tiny, so the decision was made to not remove it from the patient.The patient will follow up in one year for evaluation.There was no blood loss.There was no patient injury, medical/surgical intervention required.The patient was in stable condition.The procedure was completed successfully.

• Brand Name: UNK GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10458707
• Report Number: 2243441-2020-00047
• Device Sequence Number: 3219054
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: 04987350773210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/27/2020
• Report Date (Section F): 08/27/2020

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 Lot Number: 200109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2020
• 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: 50 YR
• Patient Weight: 115
• Date Report Sent to FDA: 08/27/2020