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

Catalog Number CRV135-19P

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.(b)(4).When the device was returned to the manufacturer for evaluation, a reportable malfunction (tip separation) was recognized for the first time; therefore, the date the manufacturer became aware of this event was considered the date the device returned.The returned microcatheter was missing the distal segment of the tip.Tip breakage was microscopically observed.It found that the tip surface was scratched possibly made by contacting calcium and circumferential cracks were observed proximal to the breakage end.The polymer tip and the inner polymer layer were found stretched and ends of braids in the middle layer were exposed.These finding suggested that the tip was torn off due to tensile stress.The breakage end was located at the border between the polymer-only segment and polymer-and-braids segment, approximately 2 mm from the tip end.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for this lot.Based on the obtained information and investigation outcome, it was concluded that tip separation was attributed to tensile stress exceeding the product's design limit that was inadvertently applied on the microcatheter while the catheter tip was being trapped by the heavily calcified lesion.That tensile stress was assumed to have made the tip damaged and affected catheter manipulability; the damaged tip was eventually torn off by continuous tensile stress generated during catheter removal.There was no indication of product deficiency.Because the separated tip was not returned, a possibility could not be completely ruled out that it might be left in the anatomy.Instructions for use (ifu) states that: [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 Description

It was reported that it was difficult to cross a heavily calcified cto in the posterior tibial artery during a ppi.Another microcatheter of the same kind was replaced; however, it failed to cross due to severe calcification.A new penetration catheter was used to cross and successfully crossed the lesion.Poba was done to reestablish the blood flow.There were no adverse patient effects related to the reported microcatheter.The patient was problem-free after the ppi.

Manufacturer Narrative

Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI 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
• MDR Report Key: 7662785
• MDR Text Key: 113160419
• Report Number: 3003775027-2018-00132
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108942
• UDI-Public: (01)04547327108942(17)210131(30)1(10)180203K14A
• Combination Product (y/n): N
• PMA/PMN Number: K152447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 180203K14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other