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 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation.Visual inspection upon receipt found that the distal segment of the shaft had been fractured.The outer layer (ptfe coat) was found to have been sheared off the outer surface of the wire on the segments indicated as follows.90 - 93mm, 145mm, 1805-1810mm, 2455mm, 2490mm, 2820 - 2825mm, 3140 - 3165mm 3800 - 3805mm, 3820 - 3825mm 4000 - 4005mm and 4424 - 4494mm approximately distance measured from the distal fracture end of the device.The total length was found to be shorter than that of the product sample from the involved product code by approximately 6mm, indicating that the distal segment approximately 6mm in length is missing.Magnifying and electron microscopic inspection of the fracture end revealed the following.The urethane outer layer had been diminished toward the fracture end.The urethane outer layer on the segment adjacent to the fracture end had been creased.The gold coil was exposed at the fracture end.The outside diameter of the urethane coated segment was measured on the undamaged segment and confirmed to meet the manufacturer specifications.The urethane outer layer was dissolved for further inspection of the core wire.It was found to have been fractured.Electron microscopic inspection of the fracture end found the presence of the dimple pattern on the fracture cross-section.The lateral side of the fracture was found to be in the flat state.Electron microscopic inspection of the fracture end of the gold coil found the coil had been diminished toward the fracture end.The outside diameter of the core wire was confirmed to meet the manufacturer specifications.Magnifying inspection of the ptfe coat-sheared segments found that the outer layer (ptfe coat) had been sheared in the distal direction on some segments and in the proximal direction on other segments.The outside diameter of the ptfe coated segment was measured on the undamaged segment and confirmed to meet the manufacturer specifications.The undamaged outer layer (ptfe coat) was removed from the core wire to evaluate the adhesive strength of the outer layer (ptfe coat) to the core wire.Magnifying inspection confirmed the adhesive level was equivalent to that of the product sample from the involved product code with no lifted or gapped segment.A reproductive test was conducted.The sample was subjected to repetitive 90-degree bending forces till it became fractured.Subsequent electron microscopic inspection of the fracture revealed that the generation of the dimple pattern on the flat fracture cross-section surface.The state of the fracture was confirmed to be similar to that of the actual device was duplicated.A second reproductive test was conducted on a current product sample of the visiglide guide wire.The test sample was let to have contact with a sharp tool 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.The coating was sheared off the shaft and some sheared portions came off the shaft.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.The test sample was let to have contact with an inserter on the outer layer (ptfe coat) by pushing the outer layer (ptfe coat) segment against the inserter.In this state the test sample was pulled in the proximal direction.No damage was generated on the shaft.The test sample was fixed to a plastic torque device gently on the outer layer (ptfe coat) in this state the test sample was pulled in the proximal direction.Some scratches were generated in the distal direction on the outer layer (ptfe coat).No peeling of the outer layer (ptfe coat) occurred.The forceps elevator on the endoscope was raised while a guide wire is inserted in it.The guide wire came into close contact with the forceps elevator.Subsequently when the guide wire was subjected to further pushing and pulling forces in this state, it was exposed to a frictional force exceeding the product's strength limit, resulting in shearing of the outer layer (ptfe coat) off the shaft.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the investigation, it is likely that the cause of the fractured guide wire is due to the actual device being subjected to repetitive bending force on the distal segment.It is assumable that the core wire got fractured first due to metal fatigue.Subsequently, when the actual device was subjected to pulling force, the gold coil and urethane outer layer got fractured.From the available information, however, the definitive cause cannot be determined.As a cause of the generation of shearing of the outer layer (ptfe coat), it is likely that the actual device was exposed to abrading force which exceeded the strength limit of this product.It is, however, difficult to determine from the available information, when and how the actual device was exposed to the abrading force.A review of the device history record and the shipping inspection records of the involved product code/lot# combination confirmed there was no indication of production-related problem or of discrepancy in the inspection result.A search of the complaint file did not find any other report with the involved product code/lot# combination.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 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".(b)(4).

Event Description

The user facility reported a fracture on the involved device.After cannulation, during probing the papilla area, the distal segment of the actual sample was ripped off into the bile duct.The actual sample was changed out to a new one.The ripped segment was eliminated from the body after the est (endoscopic sphincterotomy).

• 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; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7725517
• MDR Text Key: 115189305
• Report Number: 9681834-2018-00141
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other