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

Catalog Number	CRV135-19P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device investigation could not be performed because the 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.Based on the obtained information and findings on manufacturing records, it was presumed that tensile stress generated with catheter removal had most likely contributed to the reported tip separation.The applied stress would exceed the product design limit when the catheter tip was being caught and restricted its movement by heavy calcification.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [contraindications] do not use this microcatheter in advanced calcified lesion; [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); and, [malfunctions] separation.
Event or Problem Description
It was reported that the tip of an asahi caravel microcatheter was separated and remained in the patient during a pci to treat a moderately tortuous, severely calcified 75-90% occlusion in the rca.The lesion was wired successfully with an asahi fielder fc guide wire and the microcatheter was placed over the guide wire and successfully navigated all the way distal across the lesion.The guide wire was pulled and replaced with a rota wire floppy guide wire.The microcatheter was being removed but got stuck in the proximal highly calcified 1/3rd of the rca.At the point where the catheter looked to be stuck, the physician continued to pull and noticed the tip of the microcatheter separated from the shaft.Several attempts were made to recover the tip but they were not successful.Angioplasty and stent procedure on this patient's artery were unable to be performed due to anatomy.
Additional Manufacturer Narrative
The reported caravel microcatheter was returned for evaluation.The returned microcatheter was missing its entire tip approximately 5mm in length.Microscopic observation found that circumferential scratches likely made by calcified plaque were on the polymer-jacketed shaft proximal to the torn end of the tip.Strands on the shaft were disarranged.The catheter lumen was narrowed by the inner polymer jacket and braid tube that were gathered inward.These findings indicated that torsion had most likely contributed to separation of the tip.Based on the provided information and findings on investigation, it was presumed that torsion generated with catheter manipulation had most likely contributed to the reported tip separation.The applied stress would exceed the product design limit when the catheter tip was being caught and restricted its movement by the highly calcified lesion.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [contraindications] do not use this microcatheter in advanced calcified lesion; [warnings] do not rotate this microcatheter in any situation.(rotating this microcatheter may cause damage to the microcatheter, and may also damage the blood vessel.); [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.); and, [malfunction and adverse effects] separation.

• Brand Name: ASAHI 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
• MDR Report Key: 9724048
• Report Number: 3003775027-2020-00036
• Device Sequence Number: 10850824
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)200831(10)170912K231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 08/31/2020
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 170912K231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 07/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 80 YR