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

Model Number	CSR150-21S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percutaneous coronary intervention (pci) for a chronic total occlusion (cto) lesion in segments #1-3 of the right coronary artery (rca) was performed by the retrograde approach with a finecross microcatheter (terumo) and an asahi suoh 03 guide wire by way of the first septal branch.As a stent had been already deployed, the finecross microcatheter could not be advanced.After an unspecified balloon catheter was inserted and dilated up to its rated burst pressure (rbp), the finecross microcatheter was replaced by an asahi corsair pro xs microcatheter.Advanced over the suoh 03 guide wire and went through a stent strut, the asahi corsair pro xs microcatheter was trapped, and approximately a third of the tip segment of the microcatheter was left in the patient anatomy.A new asahi corsair pro xs microcatheter was used to approach from a different septal branch with success.An unspecified stent was deployed in the target lesion, and the procedure was completed.It was informed that there were no adverse patient effects caused by the event.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: (b)(4).The reported asahi corsair pro xs microcatheter was returned for investigation.The returned asahi corsair pro xs microcatheter was found with its concomitantly used suoh 03 guide wire inserted inside, which was coming out of the tip end of the microcatheter for approximately 180mm.The guide wire could not be removed from the microcatheter.Microscopic observation found that the tip segment of the asahi corsair pro xs microcatheter was twisted and stretched from approximately 3mm distal to the shaft-tip junction.The tip segment was torn off at approximately 8mm distal to the shaft-tip joint.The torn end was oblique, indicating that the catheter tip had been caught by the stent strut and torn off.X-ray observation of the distal segment of the asahi corsair pro xs microcatheter found that the inner braids were disarranged at approximately 3mm distal to the shaft-tip joint and got stuck with the suoh 03 guide wire.Measurement of the stretched and torn distal end of the catheter tip could not identify the length of the detached tip fragment.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 the investigation outcome, it was presumed that rotational stress might have been applied to the subject asahi corsair pro xs microcatheter while its distal tip segment had been caught by the stent strut during the attempts to advance the microcatheter through the stent strut, twisting the catheter tip and deforming the inner braids.Consequently, the microcatheter and its concomitantly used suoh 03 guide wire got stuck to each other.As tension was locally accumulated on the distal segment of the catheter tip during withdrawal attempts, the tip polymer was detached.It was concluded that this event was not attributed to product quality.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings] 1) do not use this microcatheter in advanced calcified lesions.2) do not use this microcatheter in lesions through strut of stent.12) 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.) 13) 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] 1) malfunction separation trap with guide wire.

• 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: yukimi nagumo ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 21146910
• Report Number: 3003775027-2025-00001
• Device Sequence Number: 9190244
• Product Code: DQY
• UDI-Device Identifier: 04547327123679
• UDI-Public: (01)04547327123679(17)270731(10)240731K091
• 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): 01/14/2024

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 Model Number: CSR150-21S
• Device Lot Number: 240731K091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 77 YR
• Patient Sex: Male