MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

The user facility reported that during endoscopic retrograde cholangiopancreatography (ercp), an area of about 5 centimeters of bare metal without coating was visible on the guidewire, about 1 m from the tip.Due to this, the resistance was quite strong, and insertion was not possible.It was reported that the coating had not fallen off in the patient's body and was uncoated from the beginning.The device was replaced with a similar device and procedure was completed.There was no patient injury or medical/surgical intervention required.The final patient impact was not harmed.The event occurred intra-operative.

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name - requested, not provided.Health professional- requested, not provided.Occupation- requested, not provided.The actual was returned for investigation.Visual inspection of the actual sample found no breakage or other visible anomaly in the appearance.Magnifying inspection of the actual sample found that the outer layer (ptfe coating) had been peeled off in the area approximately 100 mm to 150 mm from the distal end.The peeling had occurred from the distal to proximal and in the opposite direction.No peeling or other external anomaly was observed in the areas other than the above-mentioned.The undamaged ptfe coating was removed from the core wire to evaluate the state of the adhesion of the ptfe coating to the core wire.Magnifying inspection confirmed that there was no lifted or gapped section in the ptfe coating and that it was equivalent to that of a normal sample.The outer diameter of the actual sample was measured as follows and confirmed to be within the factory's control standards.No dimensional anonaly was observed.Outer diameter of the urethane-coated section was approximately 0.59 mm.Outer diameter of the distal area of the ptfe-coated section was approximately 0.60.Outer diameter of the proximal area of the ptfe-coated section was approximately 0.58 mm.Review of the manufacturing record and the product-release judgment record of the involved product/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination from other facilities.The following simulation tests were conducted in the past: i) a test sample was pulled in the proximal direction while a metal plate (1 mm in thickness) was put against the outer layer (ptfe coating) surface.As a result, peeling of ptfe coating occurred toward the distal end.When the test sample was pushed in the distal direction under the same condition, the ptfe coating was peeled toward the proximal end.Ii) a test sample was pulled in the proximal direction while an inserter that came with the product was put against the ptfe coating surface.No peeling of ptfe coating was observed.Iii) a test sample was pulled in the proximal direction while a plastic torque device was attached loosely to the ptfe-coated area.Multiple abrasions were caused from the proximal to distal, however, no peeling of ptfe coating was observed.Based on our experience, it is known that the peeling of ptfe coating may occur when the guidewire is pushed or pulled while the forceps elevator is in the lifted-up position.The state of the actual sample seemed similar to this state.Based on the results of the investigation, it was considered that this case was caused by an increase in sliding resistance due to the peeling of the outer layer (ptfe coating) of the actual sample, which led to insertion failure.The peeling of the outer layer (ptfe coat) was considered to have been caused by an abrasion load exceeding the limit strength of the product in a state when some hard object (such as the device being used in combination with the actual sample) was in strong contact with the actual sample.However, as the details of the occurrence situation were unknown, the timing of the occurrence could not be clarified.With regard to the description of the event, "it was observed that there was an area of about 5cm in the guidewire where bare metal without coating was visible, at about 1 m from the tip", it was presumed this referred to the area around 1350 mm from the tip, which is the joint of core wires.This is uncoated area in accordance with the product specifications.Relevant ifu reference: "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." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15051120
• MDR Text Key: 304552421
• Report Number: 9681834-2022-00135
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 1YK (211110)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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