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

Catalog Number SA145-33N

Device Problem Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 05/19/2021

Event Type  Death  

Manufacturer Narrative

Manufacturing site: asahi intecc ((b)(6)) co., ltd., pathum thani, (b)(6), registration number: (b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Findings of production records did not confirm quality issues.Based on the provided information, it was presumed that the tip or outer tube of the sasuke was likely crushed due to calcified anatomy, increasing resistance between the catheter lumen and the rg3 guide wire.Or the tip of the sasuke could be trapped in the lesion.Either way, it was concluded that difficulty in removal was not attributed to product quality.Although the guide theter had most likely caused the reported ascending aorta dissection, potentiality could not be completely ruled out that forceful removal of the stuck sasuke might have indirectly contributed to the dissection.No capa will be taken.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].Withdrawal difficulty, dissection of blood vessels.

Event Description

It was reported that a percutaneous coronary intervention (pci) was performed to treat a moderately calcified, chronic total occlusion (cto) in the right coronary artery (rca).After externalization was achieved with an asahi rg3 guide wire, a des was implanted in the rca.The an asahi sasuke double lumen catheter was advanced for distal antegrade wiring to complete stenting of the posterolateral artery.At this point, both the sasuke and the retrograde asahi corsair pro xs microcatheter got stuck on the rg3.After many attempts, a destroyed sasuke was able to be removed from the guiding catheter.Because the corsair pro xs microcatheter was stuck on the rg3 and unable to be removed, it was removed together with the rg3.The case was very complex and this procedure was a reattempt and was complicated by ascending aorta dissection and perforation of the collateral used for the retrograde approach.The patient suffered cardiac arrest, resuscitation, pericardial tamponade treated with drainage and expired in the ccu 12 hours after the pci.Corsair pro xs: mfr report # 3003775027-2021-00123.Sasuke: mfr report # 3003775027-2021-00124.Rg3: mfr report # 3003775027-2021-00125.

• 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: 12132754
• MDR Text Key: 260412656
• Report Number: 3003775027-2021-00124
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327120180
• UDI-Public: (01)04547327120180(17)231231(10)210116F011
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K182844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: SA145-33N
• Device Lot Number: 210116F011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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): Death; Life Threatening; Required Intervention