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

Catalog Number	SA145-33N
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4), 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.Based on the provided information, result of lot history records review, and referring to know similar events, it was presumed that the unspecified balloon used to trap out sasuke had likely trapped the sasuke tip during removal; therefore, tensile stress generated with removal exceeded the product design limit.Consequently, the tip became detached.It was concluded that this event was not attributed to product quality.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] separation.
Event or Problem Description
It was reported that the tip of an asahi sasuke double lumen catheter had separated during a percutaneous coronary intervention (pci) to treat a moderately tortuous, eccentrically calcified, 99% stenosis (30mm) in the mid left anterior descending artery (lad).A non-asahi 6 fr mach 1 fcl guide catheter was engaged.A non-asahi runthrough guide wire was delivered to the lad, and an asahi prowater guide wire was delivered to the diagonal branch, and another runthrough was delivered to the circumflex artery for protection.Once prowater was placed in the diagonal branch, sasuke was trapped out with difficulty.Resistance was met during removal.After coming out, the physician realized on fluoroscopy that part of the catheter tip was dislodged and remained in the main vessel wire.A 1.5mm unspecified balloon was used to push the tip fragment further down the peripheral lad.The patient was fine without issue after the procedure.
Additional Manufacturer Narrative
User facility report mw5107231 was received via the us importer.B3.Date of event was updated accordingly.

• Brand Name: SASUKE
• Common Device Name: 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: 13539638
• Report Number: 3003775027-2022-00022
• Device Sequence Number: 3868174
• Product Code: DQY
• UDI-Device Identifier: 04547327120197
• UDI-Public: (01)04547327120197(17)240430(10)210504F041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: SA145-33N
• Device Lot Number: 210504F041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 53 YR
• Patient Sex: Female