|
Date of birth - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).Health professional: requested, not provided.Occupation: requested, not provided.Device manufacture date - unknown due to unknown lot number.(b)(4).The actual device was returned for evaluation.Visual inspection upon receipt revealed that the shaft had been fractured into two pieces at approximately 260mm from the distal end of the device.The shaft had been deformed on approximately 20 -50mm from the distal end of the device.The outer layer (ptfe coat) had been sheared off on approximately 75 - 80mm and 150 - 390mm from the distal end of the device.The total length was found to meet manufacturer specifications of this product code (=approximately 4500mm).The fractured distal section measured approximately 260mm.The proximal main body measured approximately 4240mm.In total: approximately 4500mm.Magnifying and electron microscopic inspections of the fractured sections obtained the findings as follows.The outer layer (ptfe coat) had been sheared off on the lateral section adjacent to the fracture end.The fracture end had a flat shape.The generation of the dimple pattern was found on the fracture cross-section.Magnifying and electron microscopic inspections of the deformed section revealed some abrasions generated on the outer surface.Magnifying inspection of the ptfe coat-sheared segment found that the shearing of the outer layer had occurred in the distal form the proximal and in the proximal from the distal directions.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.The outside diameter was measured on the undamaged segment and confirmed to meet manufacturer specifications.Functional testing was conducted.The sample was subjected to repetitive 90-degree bending forces until 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.Functional testing was conducted on a current product sample of the visiglide guide wire: 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.The coating was sheared off the shaft and some sheared portions came off the shaft.The forceps elevator on the endoscope was raised while a guide wire was inserted.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.The following potential lot numbers, 171109, 171113 and 171127 were traced back from the reported production number of (b)(4).A review of the device history record and product release decision control sheets of the involved product/lot# was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, the cause of the fractured guide wire shaft was likely due to the actual device being subjected to repetitive bending force at approximately 260mm from the distal end of the device and became fractured first due to metal fatigue.From the available information, however, the definitive cause cannot be determined.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.However, it is difficult to determine from the available information, when and how the actual device was exposed to the abrading force.The cause of the deformed guide wire shaft, it is likely that the actual device was subjected to external force, including bending force and abrading force, which exceeded the strength limit of this product code, resulting in the generation of deformation.However, it is difficult to determine from the available information, when and how the actual device was exposed to the external force.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 endotherapy accessory." (b)(4).
|
|
The user facility reported that during the very first case, the single use guidewire had "broke" near the 10cm mark when he was performing an ercp case.The distal part of the broken wire became stuck in the cbd; however, with the great efforts of the doctor he was able to remove the broken piece of the wire from the cbd.There was no harm or injury to the patient reported.The piece of the wire that had dislodged in the patient was retrieved with the use of a snare and forceps.The procedure outcome is unknown.The final patient impact is unknown.
|
