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

Catalog Number SA145-33N

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site: (b)(4), registration number: (b)(4).When the device was returned to the manufacturer, a reportable malfunction was recognized for the first time; therefore, the date of this report and the date received by the manufacturer were considered the date the device returned.The sasuke catheter was returned for evaluation.There was a crush with partially bulged portion on the distal side of the outer shaft tube at approximately 30mm from the tip.The wire port was longitudinally ripped.The shaft tube was torn apart at approximately 400mm from the tip.Microscopic observation on the torn end of the shaft tube confirmed a trace of ductile rupture on the mid shaft tube.Two core wires and the inner tube were exposed at the torn end of the shaft tube.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 with removal had most likely contributed to the observed tearing of the outer shaft tube of the returned sasuke catheter.The applied stress would exceed the product design limit and tear the mid and proximal shaft tubes apart at the welded joint likely when the sasuke was inadvertently pressed against the arterial wall by the exchange catheter.The damage observed at the wire port was likely made when interfering with the guide wire that was inside the rapid exchange lumen at the time the sasuke was pressed by the exchange catheter; the guide wire was pulled with the fixed sasuke, became deflected, and pushed against the wire port to tear.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; and, [malfunction and adverse effects] damage (separation, kink, bend, deforming, damage to the hydrophilic coating).

Event Description

It was reported that the distal part of an asahi sasuke double-lumen catheter during a pci to treat a moderately calcified 90-99% occlusion in the lcx #11.The sasuke was used with an asahi fielder xt-r guide wire in attempts to cross the lesion.To wire exchange, another asahi guide wire, sion blue, was delivered via the over-the-wire lumen of sasuke.A non-asahi exchange catheter was then delivered to remove the sasuke leaving the fielder xt-r guide wire in place; however, the attempt failed.The sasuke was removed together with the guide wire.It was noted that the wire port and the distal part of the removed sasuke was damaged.A new sasuke was replaced to resume the procedure.The pci was successfully completed with reestablished blood flow achieved by stent deployment.The patient after the procedure was fine without adverse event associated with this event.

• 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: 10544167
• MDR Text Key: 209211217
• Report Number: 3003775027-2020-00144
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108553
• UDI-Public: (01)04547327108553(17)230331(30)1(10)200401F041
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: SA145-33N
• Device Lot Number: 200401F041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• 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