MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION SINGLE USE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

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.This is the preliminary report based on the review of relevant records as follows: · since the lot number was unknown, the investigation could not be performed.· for approximately past three years (august, 2020 - as of july, 2023), no deviation or non-conformance related to the involved event for the product with the involved product code was found.The actual sample will be evaluated upon its arrival at ashitaka factory.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 during the procedure, the stent could not be inserted due to the peeled coating of guidewire.Both the guidewire and stent were replaced with same products, and the procedure was completed.There was no effect on the patient.The person in charge of the facility was not able to confirm the actual sample.It was informed that peeling of the coating was speculation of the facility.The procedure was completed successfully and the patient was not harmed.

Manufacturer Narrative

This report is being sent as follow-up no.1 to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.1.Investigation of the actual sample: since it was unknown whether the actual sample was contaminated by infectious agent or not, the investigation was performed over the plastic bag.1.1.Visual inspection of the actual sample from the outside of plastic bag · it was found that the surface had been roughened in some sections.· no anomaly such as peeling of the coat was found in other sections that were possible to be confirmed.2.Record review: 2.1.History investigation of the product with the involved product code/lot number · since the lot number was unknown, the investigation could not be performed.2.2.Regarding the product with the involved product code, no defect related to peeling of the coat was found in the manufacturing process for the past 3 years (october, 2020 - september, 2023).3.Cause of occurrence/conclusion: based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.It was found that the surface of actual sample had been roughened.However, since it was unknown whether the actual sample was contaminated by infectious agent or not, detailed investigation of the roughened section could not be performed, and it was not possible to clarify the cause of occurrence.Relevant ifu reference: "before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, present an infection control risk, cause tissue irritation and patient injury such as punctures, hemorrhages, mucous membrane damage or thermal injury and may result in more-severe equipment damage." 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 GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• 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 ; 6402040886
• MDR Report Key: 17537807
• MDR Text Key: 321806112
• Report Number: 9681834-2023-00158
• Device Sequence Number: 1
• Product Code: DQX
• 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: 08/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• 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: 09/19/2023
• 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: PBD-V631 P-0807