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

Catalog Number	OL-XS25453M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number: 02k(unknown) was provided.Implanted date: device was not implanted.Explanted date: device was not explanted.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 dhr and product release decision control sheet of the involved product code/all february 2020 lots was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that the wire broke during stent deployment.Ercp guidewire, straight tip.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual samples (a guidewire and a bile duct stent) were received.Visual inspection revealed that the guidewire had been fractured and the tube section of the bile duct stent had been buckled.The distal fragment was not returned.The actual guidewire sample was compared with a current product sample and confirmed that missing length was 92 mm.Magnifying inspection of the fractured section of the actual guidewire sample found that the ptfe coating near the fracture had been peeled from the distal toward the proximal direction.Electron microscopic inspection of the actual sample revealed that the fracture surface was rough.Magnifying inspection of the buckling section in the bile duct stent tube revealed a rip at approximately 140 mm from the distal end.X-ray fluoroscopic inspection of the guidewire inside the bile duct stent tube lumen confirmed there was no breakage in the guidewire.Reproductive testing was conducted and when a factory-retained guidewire was subjected to repetitive 90-degree bending load until it became fractured, a fracture surface similar to that of the actual sample was observed.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 kind of bending force with resultant fracture.From the available information, however, it was not determined when it occurred exactly.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: SINGLE USE GUIDWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10143490
• Report Number: 9681834-2020-00102
• Device Sequence Number: 17011303
• Product Code: OCY
• UDI-Device Identifier: 04953170282782
• UDI-Public: 04953170282782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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 Catalogue Number: OL-XS25453M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1