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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Lot number: requested, not provided.Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Name and address- requested, not provided.Health professional- requested, not provided.Occupation- requested, not provided.Device manufacturer date - unknown due to unknown lot number.This report has been deemed reportable based upon evaluation of the actual sample.Three fragments of guidewires were received for investigation in one package (mdr 9681834-2021-00041 and mdr 9681834-2021-00042); they are referred to as sample 1, 2 and 3.Visual inspection of samples 1,2 and 3 with the naked eye revealed that all samples had been fractured, the distal end of sample 1 had been deformed in wavy shape, and the length of sample 1, 2 and 3 was 3080 mm, 1400 mm, and 3065 mm, respectively.The fracture end of sample 1, 2, and 3 was inspected with ccd: the fracture end of sample 1 and 2 had not been curved or tapered.Peeling of ptfe coat had been developed near the fracture ends of both samples, in the distal direction.The fracture end of sample 3 was not curved or tapered.Peeling of ptfe coat was not observed.The fracture surfaces of sample 1, 2, and 3 were inspected with electron microscope: radial pattern was observed in all the samples, the outline of the fracture surface of sample 1 and 2 seemed to match with each other.From this, it was conceivable that sample 1 and 2 were originally one guidewire, and it was conceivable that the distal 1435 mm of sample 3 was missing.Since the ptfe coat was found to have ben peeled off in sample 1 and 2, the intact part of sample 1 and 2 was cut so that the adhesion of outer layer (ptfe coat) was evaluated with ccd.No anomaly such as a gap or peeling was observed.The state of adhesion was confirmed to be equivalent to that of a normal product sample.The outer diameters of sample 1, 2, and 3 was measured at the normal section and confirmed to meet the factory's control criteria.Sample 1: urethane-coated section: 0.608mm; ptfe-coated section (distal part): 0.600mm, ptfe-coated section (proximal part): 0.575mm; sample 2: ptfe-coated section (proximal part): 0.574mm; sample 3: ptfe-coated section (proximal part): 0.572mm.Reproductive testing was carried out with a current product sample.Fracture of core wire: a repetitive bending load at a 90-degree angle was applied to the test sample until it got fractured, as a result, dimple pattern was observed on the fracture surface of the core wire.As this state if similar to that observed in the actual sample, it was presumed that the actual sample may have been subjected to a similar repetitive bending load.Peeling of ptfe coat: a test sample was pulled in the proximal direction while a metal plate (1 mm-thick) was put against the ptfe coat surface.As a result, peeling of ptfe coat occurred from the proximal to distal direction.When the test sample was pushed in the distal direction under the same condition, the ptfe coat was peeled from distal to proximal direction.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and the product-release judgement record.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.Sample 1 and 2 (presumed to be one guidewire originally): the distal end of sample 1 was caught in some object and then subjected to a pushing load repeatedly.As a result, the distal end was deformed.At the same time, a bending load may have worked on the area around 3080 mm from the distal end, which resulted in the fracture into sample 1 and 2.It was likely that the peeling of ptfe coat was caused due to sample 1 and 2 having been manipulated while a hard object (e.G.Concurrently used device) was in a strong contact with the surface.Since no concurrently used device was available for evaluation, the timing of occurrence could not be clarified.Sample 3: it was likely to have been fractured due to having been subjected to repetitive bending load; however, since the distal portion was not returned for the investigation, it was not clarified exactly when and how it occurred.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).Registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved single use guidewire was used during the ercp procedure.While performing cannula insertion, the visiglide broke.The procedure was completed with similar equipment.The procedure was completed successfully.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: 11538612
• Report Number: 9681834-2021-00042
• Device Sequence Number: 14406628
• 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): 03/22/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1