MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. TORNUS; PERCUTANEOUS CATHETER

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported through the literature that asahi tornus penetration catheter was difficult to be removed and required surgical intervention.Details are as follows: 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.

Manufacturer Narrative

Manufacturing site: manufacturing site could not be identified because the product lot number information was not available.Device evaluation could not be performed because the affected device was not returned from the user facility.Lot history records review could not be conducted because lot information was unavailable.All the shipped products were inspected in the production process and satisfied the product specifications and release criteria; therefore, it was concluded that there was no anomaly in product quality.According to the literature, removal difficulty was due to the lesion; the catheter was caught by the lesion.It was concluded that this event was associated with lesion and procedural properties, not related to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings] if any resistance or something abnormal is felt when operating this catheter, do not continue the operation while the causes are unclear.If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.If there are complications as a result of the removal of the entire system, stop immediately the percutaneous transluminal coronary angioplasty (ptca) or the percutaneous transluminal angioplasty (pta), and perform appropriate treatment at the discretion of the physician.(continuing the operation while the cause of the problem is not identified may cause damage to or breakage of the catheter, and damage the blood vessel.In the worst case, life-threatening adverse events may result.) if a strong reaction is felt in the opposite direction of rotation when the catheter is advanced toward or withdrawn from the lesion, the catheter may be caught.Operate the catheter carefully and do not forcefully continue the procedure.(it may damage or break the catheter or damage the blood vessels.In the worst case, life-threatening adverse events may result.) [malfunction and adverse events] removal difficulty.

• Brand Name: TORNUS
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 16011065
• MDR Text Key: 305775293
• Report Number: 3003775027-2022-00165
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention