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 Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site: (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.The outer shaft tube of the sasuke was torn at approximately 400mm from the tip where underlying two core wires and inner tube were exposed.The wire port was split distally for approximately 9mm.The torn end of the shaft tube was microscopically observed; the torn end of the middle shaft tube showed characteristics of ductile rupture.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 by the concomitant guide wire that was in the rapid exchange lumen at the time the sasuke was concurrently being removed and pressed by the exchange catheter; the guide wire was pulled with the fixed sasuke, became deflected, and ripped the wire port.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 an asahi sasuke double-lumen catheter was damaged during a pci to treat a cto in the lcx #11.After post dilation of a deployed stent in the left main through the lcx, the catheter was used to deliver a guide wire down to the lad through the stent's struts.A non-asahi exchange catheter was used to remove the sasuke catheter when something felt wrong.The removed sasuke was noted damage.The physician made sure that no fragments were left in the patient and resume the procedure.The pci was successfully completed.There were no adverse patient effects 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: 10571191
• MDR Text Key: 231800525
• Report Number: 3003775027-2020-00148
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108553
• UDI-Public: (01)04547327108553(17)221231(30)1(10)200107F281
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: SA145-33N
• Device Lot Number: 200107F281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2020
• 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