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

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: no patient involvement.Age & date of birth: no patient involvement.Patient sex: no patient involvement.Weight: no patient involvement.Ethnicity: no patient involvement.Race: no patient involvement.Lot number: 1xk (estimated to be 211029, 211025, 211014,211011 or 211008).Expiration date: unknown.N/a as this product code is not exported to the us market.Implanted date: no patient involvement.Explanted date: no patient involvement.Initial reporter name - requested, unknown.Health professional- requested, unknown.Occupation- requested, unknown.Device manufacture date: unknown.The actual device has been returned for evaluation.Visual and magnifying inspection of the actual sample entirely found that the outer layer (ptfe coating) had been peeled off from approximately 110mm to 130mm from the distal end.The peeling of outer layer had occurred in a straight line from the proximal to distal.No peeling or other external anomalies were observed in other areas.The normal part of the actual sample was disassembled, and the condition of adhesion of the outer layer (ptfe coating) was evaluated under a magnifier.No anomalies such as lifts or gaps were observed, and it was confirmed to be equivalent to a normal product.The outer diameters of the following sections were measured and confirmed to meet the factory's control standards.No dimensional anomaly was observed: outer diameter of the urethane coating section was 0.59mm.Outer diameter of the ptfe coating section, distal side was 0.60mm.Outer diameter of the ptfe coating section, proximal side was 0.58mm.Review of the manufacturing record and the product-release judgment record of the october 2021 lot (1xk) confirmed that there were not any anomalies in them.A search of the complaint file found no other similar reports with the october 2021 lot (1xk) from other facilities.From the investigation results, as one of the possibilities, it was inferred that the peeled part of the outer layer (ptfe coating) might have caused the coating condition of the actual sample to have been seen not uniform.As one of the possible causes of the peeling of the outer layer (ptfe coating), it was inferred that an abrasion load exceeding the product's limit strength might have been applied to the actual sample when some hard object (e.G., a concurrently used device) might have come into strong contact with the actual sample.Relevant ifu (instructions for use) reference: "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 guidewire could cause patient injury, such as punctures, hemorrhages, or mucous membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory." (b)(4).

Event Description

The user facility reported that a staff member found that the coating on involved product, g-260-2545a was not uniformed.There was patient involvement.

• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15238222
• MDR Text Key: 305512886
• Report Number: 9681834-2022-00159
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Date Manufacturer Received: 07/21/2022
• 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: COOK MEDICAL'S KNIFE (TYPE: UNKNOWN)