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 03/08/2018

Event Type  Injury  

Manufacturer Narrative

The actual device sample was returned for evaluation.Visual inspection revealed 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 0mm - approximately 100mm from the distal fracture end.The total length was found to be shorter than that of the product sample from the involved product code by approximately 80mm.This implies that the distal segment approximately 80mm in length is missing.Magnifying inspection of the fracture revealed the outer layer had been sheared off and the core wire was exposed.The fracture end had been deformed into a bent shape.The exposed core wire had been discolored.Electron microscopic inspection of the fracture end found that the fracture cross-section was in the rough state with no diminishment in the diameter toward the fracture end or no generation of scratches on the lateral side.Magnifying inspection of the ptfe coat-sheared segment revealed the exposed core wire had been discolored on 0mm - 5mm from the fracture end, the outer layer (ptfe coat) had been melted on 0mm - 10mm from the fracture end, and the outer layer (ptfe coat) had been sheared in the distal direction on 15mm - 100mm from the fracture end.The outside diameter was measured on the undamaged segment and confirmed to meet the 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.Elementary analysis of the actual device by sem-edx (scanning electron microscope energy dispersive x-ray spectroscope) detected o (oxygen) on the discolored core wire in more amount than that on the product sample from the involved product code.This result implies that the actual device was exposed to some heat load, by which the outer layer was melted and the core wire was oxidized, resulting in the discoloration of the core wire observed on the actual device.Based on the reproductive tests previously conducted by (b)(4) factory, the guide wire may get fractured when it has been subjected to one of the forces described below.It was found that the configuration of the fracture of the actual sample was very similar to that when a guide wire got fractured due to the application of pulling force in the state of being formed into a loop shape.The sample was subjected to a pulling force in the state of being formed into a loop shape till it got fractured.Subsequent electron microscopic inspection of the fracture revealed that the distal end of the fracture had been curved with the surface of the fracture cross-section in the rough state.The state of the fracture similar to that of the actual sample was duplicated.A product sample was subjected to repetitive one-way torque forces in the state of being curved till it got fractured.Subsequent electron microscopic inspection of the fracture revealed the generation of a radial pattern on the fracture cross-section surface.The state of the fracture was confirmed to be different form that of the actual sample was duplicated.The sample was subjected to repetitive 90-degree bending forces till it got 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 different form that of the actual sample was duplicated.The sample was subjected to a horizontal tensile force distal end till it got fractured.Subsequent electron microscopic inspection of the fracture revealed that the shaft had been diminished toward the end.The state of the fracture was confirmed to be different form that of the actual sample was duplicated.Reproductive tests were carried out 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.From this result, it is likely that the damage was generated on the actual sample when the actual sample 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.Review of the device history record and the shipping inspection record was unable to be conducted to the unknown lot number of the involved product.Ifu states: do not use the instrument in combination with any high-frequency therapeutic device whose electrode is in direct contact with the guide wire.There is no evidence that this event was related to a device defect or malfunction.However, the fractured guide wire: the distal end of the actual device was trapped due to some factor(s).In this state, the actual sample was subjected to pushing manipulations.By this the shaft got bent.In addition, application of rotating force to the shaft caused the shaft to form into a loop shape.In this state, the actual device was subjected to pulling force, resulting in the fracture of the distal segment.Melted outer layer (ptfe coat) and discolored core wire: it is likely that the energy emitted from the diathermic dilator used in combination with the actual device melted the outer layer (ptfe coat) and discolored the core wire.The cause-and-effect relationship between the generation of the fracture on the actual device and the diathermic dilator cannot be determined.Sheared outer layer (ptfe coat): as a cause of the generation of shearing of the outer layer (ptfe coat) on the segment where the outer layer (ptfe coat) had not been melted, 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.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the actual device was used for colon abscess drainage under endoscopic ultrasound.The abscess was punctured with an aspiration biopsy needle (olympus : na-u230h-8019) and the actual sample was placed in the abscess through the lumen of the needle.Subsequently, a diathermic dilator (century medical inc.) was used to dilate a fistula, when the actual sample got fractured and dislodged into the abscess.Under fluoroscopy, the fractured segment was confirmed to remain in the abscess.The original procedure was discontinued and there was no attempt to retrieve the fractured segment.

• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7389087
• MDR Text Key: 104083141
• Report Number: 9681834-2018-00041
• 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: 04/02/2018

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 Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/02/2018
• 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
• Treatment: ASPIRATION BIOPSY NEEDLE; DIATHERMIC DILATOR
• Patient Outcome(s): Other