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

Model Number	N/A
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	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 referring to known similar events, it was presumed that stress exceeding the product's design limit was inadvertently applied with catheter manipulation while the catheter tip was being trapped in the severely calcified lesion, and that stress led the catheter tip to be damaged and eventually torn off.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, [malfunction and adverse effects] separation.
Event or Problem Description
It was reported that a percutaneous coronary intervention was performed to treat a severely calcified subtotal occlusion in the proximal left anterior descending artery.Ablation with rotablator was planned to be performed.An asahi microcatheter was advanced into the lesion.During removal from the artery, the catheter tip became separated in the lesion.The procedure was unsuccessful and the patient went for bypass surgery.The separated tip was left in the patient.

• Brand Name: ASAHI CARAVEL
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9307203
• Report Number: 3003775027-2019-00184
• Device Sequence Number: 2448683
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)210831(10)180924K051
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 10/29/2019

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 180924K051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/11/2019
• 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: Disability