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

Catalog Number OL-XA25455

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter name: unknown.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.However, since it was unknown whether the actual sample was infectious or not, its inspection was limited to be implemented only over the peel pack.Visual inspection over the peel pack revealed that the distal section approximately 70mm in length was missing from the main body.Reproductive testing was performed.A product sample was subjected to repetitive one-way torque force till it became fractured.Subsequent electron microscopic inspection of the fracture revealed the generation of a radial pattern on the fracture cross-section surface.A product sample was subjected to pulling force in the state of being formed into a loop-like shape till it became fractured.Subsequent electron microscopic inspection of the fracture revealed the edge of the fracture was in the curved shape.A product sample was subjected to repetitive bending force at a 90-degree angle till it became fractured.Subsequent electron microscopic inspection of the fracture revealed that the fracture cross section had a dimple pattern with no diminishment of the outside diameter toward the fracture end.A product sample was subjected to one-way pulling force till it became fractured.Subsequent electron microscopic inspection of the fracture revealed the outside diameter of the wire had been diminished toward the fracture end.A review of the device history record of the product code/lot# combination was 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 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 core wire of the actual sample became fractured as the result of metal fatigue generated on it due to it being subjected to repetitive torque force at one point and subsequent pulling force ripped off the urethane outer layer, resulting in the reported complete fracture of the distal section.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that during ercp, the single use guidewire was inserted in the gallbladder duct.During application of torque force to the actual sample, it became fractured and the distal section approximately 2-3cm in length, forming a loop-like shape, remained in the gallbladder duct; and is still there.A drainage tube was placed in the gallbladder and the patient was in stable condition.

• 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 21921 ; 8002837866
• MDR Report Key: 8850471
• MDR Text Key: 152951664
• Report Number: 9681834-2019-00132
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 190328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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
• Treatment: JF-260V OLYMPUS ENDOSCOPE
• Patient Outcome(s): Other
• Patient Age: 91 YR