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

Catalog Number CRV135-19P

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The caravel microcatheter was returned for evaluation.The tip of the returned microcatheter was partially torn.There was a deep scratch on the tip surface that was made likely when it had contacted with something hard such as calcified plaque.At the torn end of the tip, both the tip polymer and the inner jacket were found stretched distally; tensile stress had most likely contributed to separation of the tip.Because the distal end of the braid tube was exposed at the torn end, it measured that the tip was torn at the junction of polymer-only and polymer-and-braid segments located at approximately 2mm from the distal end.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 investigation outcome, it was presumed that tensile stress had most likely contributed to observed tearing of the tip of the returned caravel microcatheter.The applied stress would localize, and therefore, exceed the product design limit when the microcatheter was pulled against resistance that was caused by trapping calcified plaque.It was concluded that this event was not attributed to product quality.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.); and, [malfunction and adverse effects] separation.

Event Description

It was reported that the tip of an asahi caravel microcatheter detached during a pci to treat a moderately calcified 90-99% occlusion in the lcx #11.The microcatheter was used to support an unspecified guide wire to cross the lesion.Following the guide wire, the microcatheter was pushed into the lesion in attempts to cross but failed.When the microcatheter was removed from the vessel, the tip became separated.The separated tip was located in the distal vessel and the physician determined it was unable to retrieve it and left it in situ.The procedure was resumed with a new microcatheter.Poba was performed and the blood flow was successfully reestablished.The patient was discharged without problem the following day.

• Brand Name: CARAVEL
• Type of Device: 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: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 10249014
• MDR Text Key: 200640449
• Report Number: 3003775027-2020-00100
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108942
• UDI-Public: (01)04547327108942(17)230228(30)1(10)200310K27A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 200310K27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR