MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDEWIRE

Model Number OL-XA25455

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

The actual device has been returned to the manufacturer facility for evaluation.Visual inspection found the actual device had been fractured at the distal segment.On approximately 60 mm - 70 mm from the fractured end, the outer layer ptfe coating had been sheared off the core wire.The total length of the actual device was compared with a sample from the involved product code.The actual device was found to be shorter than the sample by approximately 10 mm indicating the distal segment approximately 10 mm in length was missing.Magnifying inspection of the fractured end found the urethane outer layer had been diminished toward the fracture end.Electron microscopic inspection of the fracture did not reveal any anomalies which could be a trigger of the fracture.The urethane outer layer was dissolved away for closer inspection of the core wire.Electron microscopic inspection of the fracture cross-section of the core wire found the presence of a radial pattern on it with no generation of diminishment or flexure on the lateral side.Magnifying inspection of the outer layer on approximately 60 mm - 70 mm from the distal fracture end where the outer layer ptfe coating had been sheared off found the shearing had occurred in the distal direction from the proximal.The outside diameter was measured on the intact segment and confirmed to be within manufacturing specifications, being comparable to the current product sample.The intact portion of the outer layer ptfe coating was removed to check for the state of adhesion of the coat to the core wire.Magnifying inspection verified it was comparable to a sample from the involved product code with no lifting of the coat or gap between the core wire.Simulation testing was conducted.A product sample was subjected to repetitive one-way torque forces in the state of being curved until it became fractured.Subsequent electron microscopic inspection of the fracture revealed the generation of a radial pattern on the flat fracture cross-section surface.The state of the fracture was similar to of the actual device was duplicated.The following tests were carried out on a product sample to see the state of shearing the outer layer ptfe coating.A 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 coat was sheared off the shaft in the distal direction.When the sample was pushed in the distal direction, the coat was sheared off the shaft in the proximal direction.In another test, 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 coat off the shaft.The production lot number was not provided by the user facility which prevented a meaningful review of production and complaint records.There is no evidence this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the actual device was subjected to repetitive one-way torque force in the curved state, resulting in the fracture.As a cause of the shearing of the outer layer ptef coating, it is likely the actual device was exposed to abrading force which exceeded the product's strength limit by being abraded forcefully against a sharp object.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: 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 or endoscope.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 endotherapy accessory.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported device separation during a procedure.The following information was provided by the user facility: during implementing ercp the actual device became fractured at approximately 20 mm from the distal end of the device; the fractured segment was left in the patient's body; the procedure was discontinued due to this incident; the doctor has no plans on retrieving the fractured segment from the patient; the doctor believes there is no adverse effect on the patient's health; and the patient is doing well.

• Brand Name: SINGLE USE GUIDEWIRE
• Type of Device: GUIDEWIRE
• 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: 6979009
• MDR Text Key: 90285120
• Report Number: 9681834-2017-00224
• 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: 10/26/2017

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 Model Number: OL-XA25455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/26/2017
• 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