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

Catalog Number	CSW135-26N
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.Attempts were made to gather thorough event information during complaint processing; no further information could be obtained.Device evaluation could not be performed because the corsair microcatheter was not returned.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Reviewing of the manufacturing records found there was no indication of product deficiency.Based on the obtained information, it was presumed that torsion applied to the microcatheter exceeded the product's design limit while the tip was being trapped by the heavy calcified cto, causing damage to the tip.The damaged tip was assumed to be separated by tensile stress applied upon catheter removal from the anatomy.However, details could not be ascertained as the device evaluation could not be performed.Instructions for use states: - [warnings] do not use this microcatheter in advanced calcified lesions; - [warnings] if any resistance or something abnormal is felt when operating this product, do not continue the operation while the causes are unclear.If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the operation while the cause of the problem is not identified may cause damage to or separation of the catheter, and damage the blood vessel.Life-threatening adverse events may occur.); and, - [malfunction and adverse effects] separation.
Event or Problem Description
It was reported that the tip of an asahi microcatheter became separated during a pci to treat a heavily calcified cto in the lad.The patient was having dialysis treatment in other clinic when he went in to arrest at which point he was transferred to the hospital.The patient was shocked at least once and resumed rhythm prior to the pci.Angiogram was done which identified multi vessel disease: large left main, 90% proximal lad, mid lad cto, distal lad disease, heavily collateralized, cto of proximal circumflex, and edp of 15.A 6fr guide catheter was placed in the lad, followed by successful placement of a non-asahi stent in mid lad.Then the distal lad cto was wired with an asahi guide wire which crossed lesion and then the subject microcatheter was advanced to proximal cap of distal lad lesion as was being rotated when its tip became dislodged and remained embedded in the lesion after wire was removed.No remedial action was taken against the separated tip.The patient was transferred to icu and stable after the procedure.The patient was discharged on (b)(6) 2018 in a rehab facility.
Additional 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 CORSAIR
• 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: 7453407
• Report Number: 3003775027-2018-00080
• Device Sequence Number: 19106815
• Product Code: DQY
• UDI-Device Identifier: 04547327087964
• UDI-Public: (01)04547327087964(17)190930(10)171011K051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171933
• 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): 04/12/2018
• Report Date (Section F): 04/12/2018

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: Physician
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CSW135-26N
• Device Lot Number: 171011K051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 01/23/2020
• 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: Disability
• Patient Age: 53 YR