MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ADVANTAGE TRACK; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Race requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code has been referenced.Review of the manufacturing record and the product-release judgement record of the involved product/lot# combination confirmed there was no indication of anomaly in them.A search of the complaint file found no other report with the involved product code/lot# combination.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the doctor was attempting to cross a very calcified occluded pedal loop when they removed the wire it unraveled, and they noted that the tip of the wire was still in the patient.It was left between the first and second toe.The patient was stable, and the procedure outcome was a success.The estimated blood loss was less than 250cc.Additional information was received on 03december2021: the procedure was a left lower extremity angiogram with intervention.The wire was still in the patients left foot between their first and second toe.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual guidewire advantage track device was returned to ashitaka for evaluation.Visual inspection of the actual sample found that the distal end had been curved and an unraveled coil that did not originate from the actual sample was wrapping around that part.Magnifying inspection of the actual sample found that the distal end had been broken.Peeling, buckling and stretching of the outer layer were observed on the curved distal end.Electron microscopic inspection of the actual sample found that the broken end had been curved and the outer layer seemed torn off at the broken end.Peeling and buckling of outer layer were observed, in addition, abrasions toward the distal end were observed on the stretched part of the outer layer.The outer diameter of the actual sample was measured and confirmed to be within the control standard.The length of the outer layer of the distal section was about 223 mm.As the normal length of that part is about 250 mm, the missing length was considered about 27 mm.The unraveled coil and the outer layer were removed to expose the core wire for an electron microscopic inspection.The broken end was found curved and tapered.It is known from our past experiments that the guidewire may get broken off when it has been subjected to one of the loads described below.In addition, the state of the broken ends of the core wire presents some regularity depending on the mechanism of the breakage.Pulling load to a loop-shaped wire.The broken ends become curved and tapered.This state is similar to that of the actual sample.One-way pulling load.The broken ends become tapered but not curved.The mechanism of breakage is thought to be different from that of the actual sample.Repeated bending load at a 90-degree angle.The broken ends are not deformed in a tapered shape and dimple pattern is observed on the broken surface.The mechanism of breakage is thought to be different from that of the actual sample.Continuous one-way torque load to a bent wire.The broken ends are not tapered or curved, but radial pattern is observed on the broken surface.The mechanism of breakage is thought to be different from that of the actual sample.Based on the results of the investigation and knowledge from the past simulation test, it is presumed that the actual sample was exposed to an excessive pulling load while hold in a loop shape, which resulted in the breakage.The missing length of the actual sample was thought to be about 27 mm.As for the unraveled coil wrapped around the tip of the actual sample, its origin could not be determined because the details were unknown.Ashitaka factory assures the quality of this product by implementing the following work and inspections.Eddy current flaw detection is performed at our supplier to assure the integrity of the core wire for this product.The outside diameter of the core wire is strictly controlled to assure the strength of the core wire.100% visual inspection is performed before the packing process for any deformity such as a kink.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seem improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage of 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." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE TRACK
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13112876
• Report Number: 9681834-2021-00243
• Device Sequence Number: 3537563
• Product Code: DQX
• UDI-Device Identifier: 04987350727886
• UDI-Public: 04987350727886
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K163004
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: GAT1430
• Device Lot Number: 200710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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: .018 NAVICROSS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Hispanic