MAUDE Adverse Event Report: ASAHI INTECC TORNUS; MICROCATHETER

Catalog Number UNKNOWN

Device Problem Entrapment of Device (1212)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Publication: journal of invasive cardiology.(https://www.Hmpgloballearningnetwork.Com/site/jic/articles/frequency-treatment-and-consequences-device-loss-and-entrapment-contemporary-percutaneous-c) title: frequency, treatment, and consequences of device loss and entrapment in contemporary percutaneous coronary interventions.[methods] we reviewed 2338 consecutive pci cases performed between 1/2005 and 5/2010 at our institution to identify cases of device loss or entrapment.The angiograms and outcomes of these patients were reviewed.[device entrapment] in contrast to device loss, 3 of 4 patients (75%) with device entrapment required emergency surgical removal and coronary artery bypass grafting.The entrapped devices were coronary guidewires (n = 2), a filterwire (boston scientific), and a tornus catheter (abbott vascular).In the fourth patient, a tornus catheter (abbott vascular) became entrapped during attempts to cross a mid right coronary artery chronic total occlusion.Attempts to advance a second guidewire next to the entrapped catheter failed and the patient required surgical removal of the catheter and coronary artery bypass grafting, followed by an uneventful recovery.

• Brand Name: TORNUS
• Type of Device: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 16004405
• MDR Text Key: 305718991
• Report Number: 3004718255-2022-00283
• Device Sequence Number: 1
• Product Code: DQY
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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: 12/19/2022
• Distributor Facility Aware Date: 11/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention