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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: n/a.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: contact: requested, not provided.E2: health professional: unknown.E3: occupation: unknown.H4: device manufacture date: february 2023.1.Since the actual sample was not returned to ashitaka factory, the analysis of it could not be performed.2.Confirmation of the provided image - an area without coating was found.- the location and length of the area in question could not be clarified from the image.*this product has a section in the vicinity of the joint of core wire (in the area approximately 1330-1355 mm from the distal end) where no ptfe is coated due to manufacturing and processing reason.From the description of the event, it was thought possible that the area reported to be missing the black coating was this uncoated section; however, this could not be confirmed since the location and the length of the uncoated area in question was unknown.3.The manufacturing record and the shipping inspection record of february-2023 lot (32k) - no anomaly was found.4.The past complaint file of february-2023 lot (32k) - no similar cases have been reported from other facilities.5.Di no.: (b)(4).(cause of occurrence).Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.From the provided image, it was inferred that the area in question was likely to be the uncoated section due to manufacturing reason in the vicinity of the joint of core wire; however, since the investigation of the actual sample could not be performed, it was not possible to identify the cause of occurrence.Instructions for use (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." 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).
Event or Problem Description
The user facility reported that they had an out of box failure, the black coating was missing from a section of the visiglide.

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: 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 ; 4103927218
• MDR Report Key: 19392377
• Report Number: 9681834-2024-00094
• Device Sequence Number: 15403603
• Product Code: OCY
• UDI-Device Identifier: 04953170358258
• UDI-Public: 04953170358258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XS35455M
• Device Lot Number: 32K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown