MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CROSSWALK; PERIPHERAL SUPPORT CATHETER

Model Number	PSC35170A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: 3009121749.The reported crosswalk support catheter was found separated in two pieces when returned for investigation.The shaft of the returned crosswalk support catheter was found detached at approximately 41cm from the proximal end.Microscopic observation of each of the proximal and distal shaft fracture ends found twisted shaft polymer with a trace of ductile fracture.From each of the fracture ends, twisted braids and inner jacket were exposed and detached.There were no other anomalies including kink or damage that could be associated with the reported event.Measurement of the returned crosswalk support catheter indicated that the entire catheter was returned although the catheter shaft was split in two.Lot history review revealed no anomaly relating to the reported case.No other similar product experience report was received from this lot.Based on the obtained information and investigation outcome, it was presumed that excessive torsional stress generated with catheter manipulation during lesion crossing attempts might have been locally applied to the shaft of the subject crosswalk support catheter.Consequently, the catheter was separated.Although it was concluded that this event was not attributed to product quality, it was conclude that possibility could not be completely ruled out that some fragment might be left in situ should the same or a similar event recur.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings]: carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out the cause of the resistance in order to avoid damage to blood vessels and separation or kinking of the product.Do not torque the product excessively while the distal part of the product crosses the stenosis or is in a stent.[malfunctions and adverse effects].Damage (separation, kink, bend, deforming).
Event or Problem Description
It was reported that an asahi crosswalk support catheter was used for a plain old balloon angioplasty (poba) to cross a moderately calcified chronic total occlusion (cto) lesion in the right superficial femoral artery (sfa).As excessive torque was applied, the subject crosswalk support catheter was separated.As the support catheter was located in an unspecified concomitant sheath, the physician pull all of the devices including the separated crosswalk support catheter pieces and removed ex situ.The physician commented that he over-torqued the crosswalk support catheter.It was informed that there was no health hazards caused by the event, and the patient was discharged.As the scheduled procedure had been halted just before the reported event occurred, another procedure was scheduled to access from a different site at a later date.

• Brand Name: CROSSWALK
• Common Device Name: PERIPHERAL SUPPORT 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: 23081154
• Report Number: 3003775027-2025-00210
• Device Sequence Number: 18571818
• Product Code: DQY
• UDI-Device Identifier: 04547327133630
• UDI-Public: (01)04547327133630(17)270930(10)240926K20A
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K192782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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
• Operator of Device: Health Professional
• Device Model Number: PSC35170A
• Device Lot Number: 240926K20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/18/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 190 KG