MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO; GUIDE WIRE

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

Jacc: cardiovascular interventions vol.16, no.9, 2023, may 8, 2023: 1109 - 1112 title: fenestration of a pk papyrus stent from an extraplaque space into the true lumen a 68-year-old man presented with recurrent instent restenosis of a saphenous vein graft to the right posterior descending artery (pda).The right coronary artery (rca) had an ostial chronic total occlusion (cto).Retrograde rca cto pci was attempted through the saphenous vein graft.A gaia next-3 (asahi intecc) wire punctured the distal cap at the pda/right posterolateral (rpla) bifurcation.A gladius mongo (asahi intec) wire was knuckled into the distal rca but exited the vessel architecture through a small branch, causing a perforation, emphasizing the importance of verification of the course of knuckles.A 3.0 × 15 mm pk papyrus (biotronik) stent was deployed retrogradely across the distal cap, sealing the perforation.The procedure was aborted.Cto pci was reattempted after 6 weeks with an excellent angiographic result.

• Brand Name: GLADIUS MONGO
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 18655492
• MDR Text Key: 334724085
• Report Number: 3004718255-2024-00323
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2024
• Distributor Facility Aware Date: 01/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male