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.6, 2023 title: tunnel in landslide technique to "block and deliver" a novel method to deliver covered stent for coronary perforation.A 63-year-old man underwent percutaneous coronary intervention of a right coronary artery (rca) chronic total occlusion for symptom improvement.The coronary arteries were engaged using 8-f guide catheters.The proximal cap was ambiguous and the occlusion long and calcified with a j-cto (multicenter cto registry of japan) score of 3 (figure 1a).Retrograde attempts failed.Antegrade dissection re-entry was attempted.A gladius mongo (asahi intecc) wire was knuckled but advanced outside the vessel architecture (figures 1b and 1c), likely through a branch resulting in ellis type iii perforation (figure 1d) and cardiac tamponade requiring pericardiocentesis.The wire was pulled and redirected into the distal rca extraplaque space (figure 1e).A 3-mm balloon was inflated on the wire to tamponade the perforation.A repeat angiogram revealed worsening extravasation (figure 1f).

• 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: 18863295
• MDR Text Key: 337183189
• Report Number: 3004718255-2024-00325
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 03/07/2024
• Distributor Facility Aware Date: 02/28/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male