MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a pacemaker insertion case, the surgeon used two glidewires during the procedure.Both glidewires got stuck inside the patient.Upon removal, the coating was noted to be broken and peeled away from both the wires.The surgeon was notified th scrub nurse, charge nurse and ordering personnel.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Review of the manufacturing record and the shipping inspection record confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot# from other facilities.Ashitaka factory was informed on february 9, 2023, that the actual sample was not available.Since the actual sample was not returned, investigation of it could not be performed.Ashitaka factory assures the quality of this product by performing following controls.The guidewires are 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 exposure of the wire or no anomaly in its appearance.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual product was not returned and investigation could not be performed, it was not possible to clarify the cause of occurrence.Ifu states: "warnings - if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glide wire m and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.Do not manipulate or withdraw the glidewire 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.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2023-00019.For the importer report see mdr 2243441-2023-00012.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to correct section d3.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16427673
• Report Number: 9681834-2023-00020
• Device Sequence Number: 16809761
• Product Code: DQX
• UDI-Device Identifier: 04987350778376
• UDI-Public: 04987350778376
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GR3513
• Device Lot Number: 220106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown