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

Catalog Number	OL-XS25453M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.However, the user facility provided a picture.From the picture, the actual device seemed to have been inserted in the holder.It was impossible to confirm the state of the distal tip section.The wire clip was found attached to the holder.Reproductive testing was performed, referring to the state of the actual sample in the provided picture, about 50 mm from the distal end of a guidewire sample was pinched firmly, and then pulled from the holder, while the wire clip was still attached to the holder.As a result, the urethane coating of distal 50 mm was peeled off.Regarding the involved product code/november 2020 production lot (0yk), review of the manufacturing record and product-release judgement record confirmed no anomaly recorded in them.It is likely that the urethane coating was peeled off 50 mm from the distal end due to an excessive tensile load having been applied to the actual sample during removal from the holder.In addition, a reproductive test showed that there was a possibility that a tensile load could have been applied to the guidewire when the guidewire was pulled from the holder while the wire clip was attached to the holder.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that pre-treatment, when the customer looked at a set of single use guidewire, they found that the coating was damaged about 5cm.They did not use the wire.The procedure outcome was not reported.The patient was not harmed.

• 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: 11811039
• Report Number: 9681834-2021-00052
• Device Sequence Number: 3224084
• Product Code: OCY
• UDI-Device Identifier: 04953170282782
• UDI-Public: 04953170282782
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1