MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE UROLOGIC WIRE; 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	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the doctor (general surgeon) was doing a portacath placement and upon retracting the glidewire he noticed that part of the polymer coating was missing.They were able to find the shaved off wire and there was no harm to patient.The patient was stable.There was no blood loss, and no patient injury and/or medical/surgical intervention required.Additional information was received on 21sept2023: no fragment was left in patient body.Product was used with a line insertion kit.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional 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.The actual device has been returned for evaluation.1.A guidewire main body and a fragment were returned.2.Visual inspection of the actual samples: - the outer layer of the guidewire main body was peeled off from approximately 62 mm to 108 mm (approximately 46 mm) from the distal end, exposing the core wire.- full length of the fragment: approximately 46 mm 3.Magnifying inspection of the guidewire main body found that: - the edge of peeled-off area at approximately 62 mm from the distal end was straight and had a step.- the outer layer of the said area had been peeled off half the circumference.- the surface of peeled outer layer was smooth.- the edge of peeled-off part at approximately 108 mm from the distal end was arc-shaped and gently sloped.- no anomaly such as a scratch was found in other sections.4.The outer diameter at the undamaged section: it met the factory's specifications.No anomaly was found.5.Magnifying inspection of the fragment found that: - each end was arbitrarily designated as end a and end b.- end a was straight, and end b was arc shaped.- the peeled-off surface was smooth.From the results of investigation 2 and 5, it was inferred that there was no portion missing from the actual sample because the edge shapes of both portions were similar, and the full length of the fragment matched the length of the peeled-off part of the main body.6.History investigation: refer to the preliminary answer card 7.Past simulation test: we have experienced that the outer layer peeled off when using radifocus guide wire m and a metal needle in combination.When the outer layer was peeled off due to the combined use with a metal needle, the following characteristics were observed.- the outer layer was peeled off half the circumference, and the core wire was exposed.- the surface of the peeled outer layer was smooth.- the distal end of the peeled piece of outer layer was straight and had a step.- the proximal end of the peeled piece of outer layer was gently sloped.These characteristics were likely to be similar to those of the actual sample.(cause of occurrence) it was likely that since the actual sample was operated in the removal direction when used in combination with a metal needle, it came into contact with the metal needle and the outer layer was peeled off.In addition, it was inferred that there was no missing part in the actual sample.(countermeasure) ashitaka factory manufacturing process assures the quality of this product by performing following work and inspections.- the guidewire is passed through the dedicated tool on 100% basis to confirm that there is no peeling of the outer layer or adhesion of any foreign substances on the surface of guidewire.- before the packaging process, 100% visual inspection is performed to confirm that there is no peeling of the outer layer on the surface of guidewire.The ifu states as follows.- do not manipulate or withdraw the guidewire m through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: RADIFOCUS GLIDEWIRE UROLOGIC WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17928209
• Report Number: 9681834-2023-00204
• Device Sequence Number: 6472611
• Product Code: KOD
• UDI-Device Identifier: 04987350754394
• UDI-Public: 04987350754394
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K923607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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 Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: UWR1035
• Device Lot Number: 220922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 02/10/2025
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/10/2023; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LINE INSERTION KIT.
• Patient Sex: Unknown