MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI CORSAIR PRO XS; PERCUTANEOUS CATHETER

Model Number	CSR150-21S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.Device evaluation could not be performed because the affected device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.As the affected device was not returned, the cause of this event could not be identified.Based on the obtained information and referring to known similar events, it was unable to completely rule out a possibility that the corsair pro xs microcatheter might have caused or contributed to the vessel perforation.Additional treatment against the vessel perforation was considered an adverse patient effect.No capa will be taken.Instructions for use (ifu) states: [warnings] ~ if any resistance or something abnormal is felt when operating this product, do not continue the operation while the causes are unclear.If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the operation while the cause of the problem is not identified may cause damage to or separation of the catheter, and damage the blood vessel.Life-threatening adverse events may occur.) ~ the microcatheter must always be operated under high-resolution fluoroscopic guidance.Particular attention should be paid when inserting or withdrawing the microcatheter into stenotic areas and narrower vessels than the product.(abrasion may result in damage or separation of the microcatheter.This may cause vascular injury and perforation, possibly leading to a life-threatening adverse event.) [malfunction and adverse effects] ~ perforation of blood vessels.
Event or Problem Description
It was reported that a percutaneous coronary intervention (pci) was performed for a mildly tortuous and mildly calcified chronic total occlusion (cto) in the left anterior descending artery (lad).An asahi corsair pro xs microcatheter and an asahi sion guide wire were advanced to the septal channel through the #4 posterior descending (pd) branch via retrograde approach.The sion guide wire was exchanged to an asahi suoh 03 guide wire and the suoh 03 guide wire could be advanced to the lad.Although the corsair pro xs microcatheter could not be advanced at first, the corsair pro xs microcatheter could be advanced with the support of a nipro 5fr guide plus guiding catheter.Using the retrograde guide wire as a marker, an asahi sasuke double lumen catheter and an asahi conquest pro 12 st guide wire were advanced via antegrade approach, but they could not cross the lesion.The guide wire was changed to an asahi gladius guide wire, to an asahi gaia next 4 guide wire and finally to an asahi conquest pro 8-20 guide wire.The conquest pro 8-20 guide wire crossed the lesion.When the retrograde sion guide wire was removed after performing reverse cart technique, perforation was observed in the septal channel.Hemostasis of the perforated site was performed by a piolax medical devices c-stopper coil (2.0*15mm).Two nipro coroflex isar neo stents (2.25*28mm, 3.00*24mm) were placed in the lad.Final angiography revealed good blood flow in the lad.It was informed that the patient was fine and discharged after the procedure.Sion: mft report #: 3003775027-2025-00236.Suoh 03: mfr report #: 3003775027-2025-00238.

• Brand Name: ASAHI CORSAIR PRO XS
• 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: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 23566081
• Report Number: 3003775027-2025-00237
• Device Sequence Number: 10272953
• Product Code: DQY
• UDI-Device Identifier: 04547327123679
• UDI-Public: (01)04547327123679(17)280331(10)250411K011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CSR150-21S
• Device Lot Number: 250411K011
• 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: 10/28/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown