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

Catalog Number CSR135-26P

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc ((b)(4).Attempt was made to gather thorough event information during complaint processing; the physician commented that the patient had no problem after the cabg.The subject catheter and the concomitant third guide wire were returned for investigation.The catheter shaft was found slightly tortuous, which could be attributed to use.The catheter tip was found with a trace of fracture due to torsion.The distal segment of the concomitant guide wire was found deformed in a hook-like shape.A twisted piece of the catheter tip fragment was found on the guide wire proximal to the middle solder at approximately 70mm from the distal end.Near the tip fragment, disarranged coils of the guide wire were found, which are typically seen when rotational force is accumulated on guide wire coils.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the obtained information and investigation outcome, it was concluded that the catheter tip was twisted by torsion exceeding the product's design limit that might be applied while the catheter tip was trapped by the lesion.As the subject catheter and its concomitant guide wire became stuck on each other, excess torsion could be inadvertently applied on the concomitant guide wire, disarranging the wire coils.It was presumed that the catheter tip was torn off due to excessive tensile force during the attempted removal.There was no indication of product deficiency.The tip was damaged too severely to exclude a possibility that tip fragment(s) might be left in the anatomy.Instructions for use states: [warnings] do not use this microcatheter to an advanced calcified lesion; [warnings] do not rotate this microcatheter in the same direction, either clockwise or counterclockwise, for more than 10 consecutive rotations.If resistance is felt while rotating this microcatheter, do not proceed with further rotation regardless of the number of performed rotations.Identify the cause of resistance under fluoroscopy, and take an appropriate action.Never continue the operation without identifying the cause.(continuing rotation may damage or break apart this microcatheter or damage the blood vessels.); and, [malfunctions and adverse events] separation.

Event Description

It was reported that during a pci to treat a heavily calcified and 95%-stenosed tortuous lesion in the lad #8, a guide wire crossed the lesion.As a small-lumen balloon catheter or another catheter could not cross the lesion under a concomitant catheter support, the subject catheter was used but had difficulty in crossing the lesion.When rotated, the catheter was trapped and withdrawn.The catheter tip was torn off and left on the guide wire, blocking blood flow to lad.An attempt was made to cross the lesion with two guide wires in parallel with a third guide wire but failed.As the patient presented with ventricular fibrillation, defibrillation was provided.Due to hemodynamic instability of the patient, transportation to another hospital was considered.When iabp and pcps were prepared and the third guide wire was withdrawn, the tip fragment of the subject catheter on the guide wire was removed from the anatomy.As timi2 flow was confirmed up to lad #7, the patent was transferred to another hospital and underwent revascularization by cabg.The physician commented that the catheter tip could be fractured due to excessive rotation and pushing forces on the subject catheter.It was reported that the patient outcome was good after cabg.

Manufacturer Narrative

Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI CORSAIR PRO
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho,; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 8447003
• MDR Text Key: 139679950
• Report Number: 3003775027-2019-00046
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108539
• UDI-Public: (01)04547327108539(17)211031(30)1(10)181123K101
• Combination Product (y/n): N
• PMA/PMN Number: K161126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CSR135-26P
• Device Lot Number: 181123K101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 57