MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDEWIRE (VISIGLIDE); ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	OL-XS35455M
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: no patient involvement.Explanted date: no patient involvement.Pma/510(k): exempt.Device manufacturer date - unknown due to unknown lot number.The actual sample was not returned to ashitaka factory for analysis.Since the lot number involved was unknown, the review of manufacturing records was performed in the following manner.Regarding the involved product, review of the manufacturing records for the past three years (april 2019 - march 2022) found no trouble or deviation in the manufacturing process that could lead to the peeling of coating.Regarding the involved product code ol-xs35455m, review of the manufacturing records for the past three years (april 2019 - march 2022) found another case in which the peeling of urethane coat and ptfe coat was reported.In this previous case, no anomaly was confirmed in the manufacturing record or the product-release judgement record, and the investigation result suggested that the damage was caused by a tensile and abrasion load applied to the product during the procedure, it was concluded not attributable to the manufacturing process.Regarding the involved product, review of the manufacturing records for the past three years (april 2019 - march 2022) found no trouble or deviation in the manufacturing process that could lead to the peeling of coating.With no actual sample available for analysis, the cause of occurrence could not be clarified.The factory is continuing diligence in maintaining the product quality through the following inspections: i) after processing the tip, 100% magnifying inspection is performed to confirm that there is no anomaly in the shape of the tip; ii) 100% visual inspection is performed during the product assembly process to confirm that there are no scratches or exposed wires; iii) before and after the ptfe coating process, sampling inspections are performed concerning the outer diameter and the abrasion resistance of the outer surface; iv) after the ptfe coating process, sampling inspections are performed concerning the slid ability and strength of coating to assure that no cracking or peeling will occur; v) before the packaging process, 100% visual inspection is performed to confirm there are no scratches; vi) during the shipping inspection process, sampling inspection is performed for the tensile strength of the tip and the outer diameter.(b)(4).
Event or Problem Description
The user facility reported that a small section of the g-240-3545s guide wire involved was stripped.This was found while loading it in the tome and before use.There was no patient involved.

• Brand Name: SINGLE USE GUIDEWIRE (VISIGLIDE)
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14187369
• Report Number: 9681834-2022-00066
• Device Sequence Number: 14573077
• Product Code: OCY
• UDI-Device Identifier: 04953170358258
• UDI-Public: 04953170358258
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 04/22/2022

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
• Operator of Device: Other
• Device Catalogue Number: OL-XS35455M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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