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

Catalog Number OL-XA25455

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6) medical center.(b)(4).The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The evaluation of the actual sample has been suspended pending the clarification of infectiousness.A review of the device history record and product release judgement control record of the involved product code/ lot# was conducted with no findings.Review of the shipping inspection record regarding outer diameter, sliding performance and strength of the distal tip against pulling force confirmed that no anomaly was noted in the inspection results of the involved product code/lot# combination.(b)(4).

Event Description

The user facility reported that the single use guidewire was used during the procedure; during ercp, the distal tip and flexible part of the guidewire were fractured.A fragment fell off in the bile duct and the fragment was retrieved with a balloon successfully with no harm to the patient's health.The procedure was suspended to be rescheduled later.Concurrently used endoscope was spyscope from bsc.Seeking was performed when the actual sample was passing through the channel of the spyscope.The actual sample reversed once; however, no problem was found at that time.Afterward, the actual sample became fractured when being withdrawn.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The infectiousness of the actual sample could no longer be confirmed; therefore, the evaluation of the actual sample was completed through the plastic bag.Visual inspection of the actual sample contained in a plastic bag revealed that it had been fractured at the distal section.No distal fragment was returned or contained in the plastic bag.The distal area of the actual sample was compared with that of a factory-retained sample of the same product code.It was confirmed that distal 70mm in length was missing.Reproductive testing was performed and a test sample with its distal part at approximately 70mm from the distal end being bent was subjected to consecutive one-way torque force.As a result, the test sample became fractured.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endotherapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endotherapy accessory.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sample was subjected to some external force and fractured.However, since the actual sample could not be subjected to close examination due to unknown infectiousness, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10231995
• MDR Text Key: 200667979
• Report Number: 9681834-2020-00129
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 200224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q290V.
• Patient Outcome(s): Required Intervention