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

Model Number	GAT1430
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while advancing an otw boston scientific coyote balloon which would not cross a lesion, the cook 5 fr x 55 cm hybrid sheath buckled in the aorta.The md tried advancing the balloon without the sheath support, which led to a kink forming in on the glidewire advantage track.014 wire.The balloon was removed, and the md proceeded to try an rx croserio 2 x 200 balloon.The balloon made it over the wire kink and successfully treated the peripheral disease in the anterior tibial artery.While removing the balloon, it wouldn't pull back over the wire kink.This led to the sheath buckling back into the aorta, so the md advanced the sheath while pulling balloon.This increased the kink in the wire and made the balloon unable to be removed.With a repeated effort to pull the balloon out, the balloon shaft broke at the monorail port, which left the balloon on the shaft of the wire and the proximal balloon shaft was removed.The md then decided to do bilateral common femoral artery (cfa) cutdowns to completely remove the wire and distal monorail balloon.These were successfully and entirely removed at this point.Medical or surgical intervention required.Estimated blood loss less than 250cc.The event occurred intra-operative.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received 29 sept 2023: the guidewire kinked but did not break.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: ir tech.Since the actual sample was not available, following investigation was performed.Review of the manufacturing record and the shipping inspection record of the involved product code/lot # found no anomaly in them.Search of the past complaint file of the involved product code/lot # found no other similar complaint from other facilities.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.Since the actual sample was not returned and the analysis of it could not be performed, it was not possible to clarify the cause of occurrence.Ashitaka factory assures the quality of this product by performing the following work and inspection.Control of the outside diameter of products 100% visual inspection prior to packaging.The instructions for use (ifu) states the following [warnings]: - if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or 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.For the importer report please see (b)(4).
Additional Manufacturer Narrative
Udi related data quality updates only.This report is being sent as follow-up 1 to correction sections d1 and d4.

• Brand Name: 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17928153
• Report Number: 9681834-2023-00205
• Device Sequence Number: 6595552
• Product Code: DQX
• UDI-Device Identifier: 04987350727886
• UDI-Public: (01)04987350727886(17)241231(10)230127
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/12/2023

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: 12/31/2024
• Device Model Number: GAT1430
• Device Catalogue Number: GAT1430
• Device Lot Number: 230127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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: BOSTON SCIENTIFIC COYOTE BALLOON; COOK 5FRX55CM HYBRID SHEATH; RX CROSERIO 2X200 BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown