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

Model Number	CRV150-19P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percutaneous coronary intervention (pci) was performed for a 90-99% stenosis in the obtuse marginal branch (om).An asahi caravel microcatheter and a terumo runthrough ns guide wire were used to cross the lesion.After crossing the lesion, the coil of the runthrough ns guide wire was found loosened and foreign object was observed on the guide wire by angiography.When all devices were withdrawn, the tip of the caravel microcatheter was torn off.It was confirmed that no fragments remained in the patient anatomy.The devices were then replaced with an unspecified guiding catheter, a caraval microcatheter, an asahi sion blue guide wire, an unspecified guide extension catheter, and an unspecified stent.The procedure was completed successfully.It was informed that there were no adverse patient effects associated with this event and the patient was discharged.
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: (b)(4).The reported caravel microcatheter was returned for evaluation with the separated tip fragment.Multiple circumferential cracks were observed on the tip polymer proximal to the torn end, which are traces of ductile tearing.At the torn end, traces of ductile tearing were observed on the inner jacket and multiple circumferential cracks were observed.Microscopic observation of the tip fragment found that the catheter tip was crushed for approximately 1mm from the tip end and scratch marks were observed on the polymer jacket.At the torn end, traces of ductile tearing were observed on the polymer jacket.Investigation of the returned microcatheter suggested that the tip segment, which is originally 5 mm in length, had elongated and torn off at approximately 2mm from the tip end, specifically at the junction of the polymer-only segment and the polymer-and-braid tube segment.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 tensile stress generated with removal might have been locally applied on the tip of the caravel microcatheter while the catheter tip was trapped by the tortuous vessel or the calcified lesion.Consequently, the tip polymer was elongated and torn off.Although it was concluded that this event was not attributed to product quality, a possibility could not be ruled out that some catheter fragments might be left in the patient anatomy if it were to recur.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings], if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel).This microcatheter must always be operated under high-resolution fluoroscopic guidance.Particular attention should be paid when inserting or withdrawing this microcatheter into or through stenotic areas, and narrower vessels than the microcatheter.(abrasion may result in damage of this microcatheter.This may cause vascular injury and perforation).Malfunctions and adverse effects, separation.

• Brand Name: CARAVEL
• 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: 23724227
• Report Number: 3003775027-2025-00247
• Device Sequence Number: 10673148
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)280331(10)250412K08A
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152447
• 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): 12/05/2025

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: CRV150-19P
• Device Lot Number: 250412K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/05/2025
• 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: 81 YR
• Patient Sex: Female