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 09/13/2019

Event Type  Injury  

Manufacturer Narrative

Age: reported to be in his 50's.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was received for evaluation.Visual inspection revealed that the outer layer (urethane coat) and the distal coil of approximately 0mm - 70mm from the distal end had been missing exposing the core wire.The core wire of approximately 0mm - 10mm from the distal end had been missing.The outer layer (ptfe coat) had been damaged on approximately 70mm-88mm and 211mm-236mm from the distal end.Magnifying and electron microscopic inspection around the distal end of the remaining urethane coat, around 70mm from the distal end, revealed that some abrasions had been generated on that area.From this, it is inferred that the urethane coat was removed by having been exposed to a hard object.The fracture end of the core wire was inspected under a magnifier and an electron microscope and revealed that the distal end had been deformed in a tapered shape toward the distal direction.From this, it is inferred that the actual device was exposed to pulling force.The outer diameter of the core wire on the intact segment near the fracture end was measured and confirmed to be comparable to that of the reference sample from the current product.Magnifying inspection of the segments where the damage on the outer layer (ptfe coat) was observed revealed that the outer layer had been sheared off in the distal direction.Based on this, it is conceivable that the actual device in the state of being in contact with a hard object was pulled in the withdrawal direction.The undamaged outer layer (ptfe coat) was removed from the core wire to evaluate the state of the adhesion of the outer layer (ptfe coat) to the core wire.Magnifying inspection confirmed it was equivalent to that of the current product sample with no lifted or gapped section on the coat.Reproductive testing was performed with two current product samples.The test sample was subjected to horizontal tensile force on the distal end until it became fractured.Subsequent electron microscopic inspection of the fracture revealed that the shaft had been deformed in a tapered shape toward the distal end.This state was found to be similar to that of the actual device.The test sample was let to have contact with a sharp tool (in this test, a metal plate approximately 1mm in thickness was utilized) on the ptfe coated segment by pushing the ptfe coated segment against the sharp tool.In this state, the test sample was pulled in the proximal direction.As a result, the coating was sheared off the shaft in the distal direction.Subsequently, the test sample was pushed in the distal direction.As a result, the coating was sheared off the shaft in the proximal direction.From this result, it is likely that the damage was generated on the actual device when the actual device was pulled in the proximal direction.A review of the device history record and product release decision control sheets 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 endo therapy accessory and determine the cause by fluoroscopy.Continuing to manipulate the guide wire 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 the actual device in the state of being in contact with a metallic stent at approximately 236mm from the distal end was pulled in the withdrawal direction, and as a result, the outer layer (ptfe coat) had been shared off the core wire; the point of approximately 70mm from the distal end of the actual device, where a bank is created as per the specified design, was caught in the metallic stent; the actual device in that caught state was pulled in the withdrawal direction, and as a result, the outer layer (urethane coat) and the distal coil segment of about 70mm in length and the core wire of distal 10mm in length were separated and missing; as one of possible factors that caused the actual device to get caught in the metallic stent, it was presumed to be due to the tortuous bile duct.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 involved single use guidewire was used for biliary metallic stent placement.After a metallic stent (sme-200p-08080) was placed in the patient's bile duct without any problem, while the metallic stent delivery system was pulled out, the actual device was caught in it and fractured.About 7 cm of the tip remained in the patient's bile duct.Considering the patient's condition, the remaining distal segment tip was not recovered and was left as it was.The patient's condition was reported to be stable.

• 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: 9197780
• MDR Text Key: 174506623
• Report Number: 9681834-2019-00172
• 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: Physician
• Type of Report: Initial
• Report Date: 10/16/2019

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: 190319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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
• Patient Outcome(s): Required Intervention