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

Catalog Number OL-XA25455

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was received for evaluation.Visual inspection upon receipt revealed that the shaft had been fractured into two pieces at approximately 95 mm from the distal end of the device.A kink was noted at approximately 75 mm from the distal end of the device.The total length was found to meet the manufacturer specification, finding it unlikely that there was no missing section.Fractured distal section: approximately 95 mm.Proximal main body: approximately 4405 mm.In total: approximately 4500 mm.Magnifying and electron microscopic inspections of the fractured sections obtained the findings as follows.The outer layer (ptfe coat) had been ripped off on the lateral section adjacent to the fracture end.The shaft had been flexed toward the fracture end.Some part of the surface of the fracture cross-section was in the rough state.Magnifying and electron microscopic inspections of the kinked section revealed that the urethane outer layer had been partially torn.The outside diameter was measured on the undamaged segment and confirmed to meet manufacturer specification.Functional testing was conducted.A test sample was subjected to pulling force in the state of being formed into a loop shape till it became fractured.Subsequent inspection of the fracture revealed that the distal end of the fracture had been flexed toward the fracture end with the surface of the fracture cross-section being in the rough state partially.The state of the fracture was confirmed to be similar to that of the actual device.A review of the review of the device history record and product release decision control sheets of the involved product /lot# combination was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.With the absence of the angiography tube used in combination with the actual device, it is difficult to determine the cause of this complaint definitely.Based on the investigation results, it is likely that the distal section of the actual device was trapped due to some factor(s).In this trapped state, the actual device was further pushed forward, due to which the actual device became bent.Subsequently, in the bent state, the actual device was subjected to torque manipulation, which led the actual device to form into a loop-like shape.Finally, when pulling force was applied to the actual device, it became fractured at the peak of the loop.As a cause of the generation of the kink on the actual device, it is likely that the actual device was exposed to external force, such as bending force and became kinked with the generation of a tear in the urethane outer layer at the kink.From the available information, it cannot be determined when and how the actual device was exposed to the external force.However, the exact cause of the reported event cannot be definitively determined based on the available information.The 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 endo therapy accessory." (b)(4).

Event Description

The user facility reported that the distal section of the involved single use visiglide guidewire became fractured.When the actual sample was inserted and advanced in an angiography tube, the distal end of the actual sample would not come out of the distal end of the angiography tube.The user withdrew the tube and actual sample together as one unit for check.It was found that the actual sample had been fractured inside the tube.It was reported that there was no harm to the patient.An unknown competitor's angiography tube was used with the involved device.The procedure outcome was reported to be unknown.The final patient impact was reported to be unknown.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8250589
• MDR Text Key: 133854586
• Report Number: 9681834-2018-00240
• 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: 01/15/2019

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 Expiration Date: 07/31/2021
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 180828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• 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