MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	OL-XA35455M
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the device history record and the shipping inspection record of the involved product/lot# combination confirmed that there were not any indications of production-related problems or any nonconforming indications in the shipping inspection result.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guidewire and/or endo therapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guide wire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory.- do not insert the instrument into the endoscope or endo therapy accessory unless movements of the instrument can be observed under clear endoscopic or x-ray image.If you cannot see the distal end of the insertion potion in the endoscopic or x-ray image, do not use the instrument.Otherwise unintended movements of the instrument could cause patient injury, such as punctures, hemorrhages or mucus membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.However, based on the reproductive tests previously conducted, the guide wire may get fractured when it has been subjected to force.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The user facility reported a fray and the tip broke off in the liver.The needle was withdrawn and procedure aborted.The patient was hemodynamically stable throughout the procedure.The procedure outcome and the patient's condition is unknown.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide information in section b3.It was initially reported the date of event was (b)(6) 2018, however, additional information was received and the date has been updated.

• Brand Name: SINGLE USE GUIDWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7393259
• Report Number: 9681834-2018-00045
• Device Sequence Number: 18881097
• Product Code: OCY
• UDI-Device Identifier: 04953170358265
• UDI-Public: 04953170358265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 10/31/2020
• Device Catalogue Number: OL-XA35455M
• Device Lot Number: 171101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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