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

Catalog Number OL-XA25455

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted explanted date: device was not explanted the actual guide wire sample and a competitor's cannula were returned for evaluation.Visual inspection of the guide wire found that the distal end had been fractured.The distal 20mm of the outer layer (ptfe coating) had been sheared off.The length of the actual sample was compared with that of a factory-retained guide wire of the involved product code.Distal 72mm of the actual guide wire sample was missing.The fracture end of the actual guide wire sample was inspected with ccd and sem and revealed: the fracture end had been curved and tapered; a step-like crack was observed in the periphery of the fracture surface, from this, it is likely that an edged tool came into contact with that area; dimples had been generated on the fracture surface.Magnifying inspection of the sheared off ptfe coating area revealed that the shearing had been developed in the distal direction.Based on this, it was assumable that the ptfe coating was sheared off while the actual guide wire sample was manipulated in the withdrawal direction.The undamaged section of the actual guide wire sample was split lengthwise to see the adhesion condition of ptfe coating.With ccd, it was confirmed to be similar to that of the current product.No gap was observed under the ptfe coating.The outer diameter of the actual guide wire sample was measured and confirmed to meet the factory specifications.The outer diameter of the core wire near the fracture was measured and confirmed to be equivalent to that at approximately 72mm from the distal end of the current product sample.Od of the distal side of ptfe coating0.577mm; od of the proximal side of ptfe coating: 0.576mm; od of the core wire near the fracture0.264mm; od of the core wire of the current product at approximately 72mm from the distal end: 0.264mm.Visual inspection of the cannula did not find any anomaly including a kink in the appearance.Magnifying inspection of the cannula revealed that the distal edge had been bent inward partially, from this, it likely that the distal end of the cannula was hooked by some object.There was no crush or no other visible anomaly on the remainder part.X-ray fluoroscopic inspection of the cannula revealed that the distal fractured piece of the actual sample was inside the hub.The fractured piece had been twisted.No other obstruction was observed in the lumen.Reproductive testing was performed, and a factory-retained guide wire sample of the involved product code was hold in loop shape, and then exposed to pulling force until it became fractured.Magnifying inspection with ccd and sem revealed that the state of fracture was similar to that observed on the actual sample.A guide wire sample was withdrawn proximally while a metal plate of 1mm in thickness was put on the ptfe coating.As a result, ptfe coating was shared off in the distal direction.When the guide wire was pushed forward, the ptfe coating was sheared off in the proximal direction.A review of the device history record and product release decision control sheets of the product code/ subjected lot#'s combinations were conducted with no findings.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 endo therapy 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 endo therapy 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 that the fracture in the actual sample was caused by the following mechanism: the ptfe coating of the actual sample had been sheared off for some reason; due to the sheared off ptfe coating, resistance was felt when the customer inserted the actual sample in the cannula; when removed from the cannula, the actual sample hooked the distal edge of the cannula causing the inward-bent deformity; while being subjected to further pulling manipulation, the actual sample twisted inside the hub due to some factors, and fractured finally.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4).Is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved single use guidewire was used during ercp, resistance was felt when the actual sample (g-260-2545a) was inserted in a cannula.When the actual sample was removed from the cannula, it was found that the distal flexible section had been fractured.There were no residues in the patient body.There was no harm to the patient.The procedure was completed successfully.There was no immediate patient impact, the final patient impact was not reported.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 9898340
• MDR Text Key: 240620506
• Report Number: 9681834-2020-00043
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 190904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1