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

Catalog Number SA145-33N

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: (b)(4).Registration number: (b)(4).The reported sasuke was returned for evaluation.Microscopic observation of the distal segment of the returned sasuke revealed that the tip segment was torn off.Traces of ductile tearing by tensile stress were observed on the shaft tube at the torn end.Proximal to the torn end, multiple scratches were observed on the shaft tube, which were likely caused due to interference with a relatively hard and sharp-edged object.Investigation of the returned microcatheter suggested that the whole tip segment was torn off at approximately 4.5mm from the distal end of the tip.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and investigation outcome, it was presumed that tensile stress generated during removal had most likely contributed to the separation of the catheter tip.As the tip was being caught and restricted its movement by the lesion that was likely relatively hard and sharp-edged, the applied stress would exceed the product design limit, making the tip tear off.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [precautions] this product must be manipulated while checking this product's motion under high-resolution x-ray fluoroscopy.In addition, if any resistance is felt during the manipulation of this product, interrupt the manipulation, and check the cause under high-resolution x-ray fluoroscopy.[malfunctions and adverse effects] separation.

Event Description

It was reported that the tip of an asahi sasuke microcatheter had separated during a percutaneous coronary intervention (pci) to treat a mildly tortuous, moderately calcified 75-90% stenosis in segment #6 of the left anterior descending artery (lad).After advancing an asahi sion blue guide wire into the high lateral branch, the sasuke was delivered over the sion blue.When attempting to advance an asahi minamo guide wire into the segment #6 via the over-the-wire lumen of the sasuke, the distal segment of the sasuke was found stuck in the high lateral branch.When removing the sasuke, the catheter tip became separated and the separated tip migrated to peripheral high lateral branch.Given that attempts to remove the catheter fragment using a snare could be difficult and there was no hemodynamic issue, the physician decided to leave the fragment in situ.The procedure was then resumed and successfully completed with reestablished blood flow achieved by stenting in segment #6.There was no change in patient condition related to this event after the procedure.

• Brand Name: SASUKE
• 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: 16011888
• MDR Text Key: 305786421
• Report Number: 3003775027-2022-00166
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• 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

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SA145-33N
• Device Lot Number: 220517F031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• 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): Disability