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

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

E1: establishment name: (b)(6).The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Since the involved lot number was unknown, the investigation could not be performed.Regarding the involved product code, there was no deviation or nonconformance related to the reported event in the past three years (december 2020 - november 2023).Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that when the inner catheter of the sx biliary stent was pulled out to release the stent, the inner catheter was torn off and the stent could not be released.Another stent was used to complete the procedure.There was no health hazard to the patient.The procedure was completely successfully.The final patient impact was not harmed.There was no medical or surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide an update to section d4, provide the device return date in section d9, update section h3, and to provide the completed investigation results.Due to the infection status of the actual sample was unknown, it was inspected visually through a plastic bag.The actual sample was in a state combined with the inner catheter which had been used with the actual sample.The distal end of the actual sample was deformed.As far as it could be seen through the plastic bag, there was no anomaly in the appearance such as a scratch that could be the factor of deformation of the actual sample in the vicinity of the deformed site.No fracture was observed in the actual sample.As far as it could be seen through the plastic bag, there was no anomaly in the appearance in other parts of the actual sample such as a scratch that could lead to the fracture of the concurrently used inner catheter.Deformation of the actual sample: based on the results of the investigation, as one of the possibilities in this case, it was inferred that some kind of external load was applied locally to the actual sample leading to the deformation; however, since the actual sample could not be examined closely due to its unknown infection status, the cause of the occurrence could not be identified.Based on the results of the investigation, to the extent that could be examined through the plastic bag, the actual sample had not been fractured and had no anomaly such as a scratch that could lead to the fracture of the concurrently used inner catheter.However, since the infection status of the actual sample was unknown and a detailed investigation could not be performed, the cause of this complaint could not be identified.Relevant instructions for use (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.".

• Brand Name: SINGLE USE GUIDEWIRE
• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18168545
• MDR Text Key: 328515527
• Report Number: 9681834-2023-00242
• 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,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/25/2023
• 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: 2007007PT SX BILIARY STENT