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

Catalog Number	CSR150-26P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #: e2015028.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.Reviewing of the production records found no indication of product deficiency.Based on the provided information, it was presumed that continuous torsion that exceeded the product's design limit was possibly applied in attempts to cross when the catheter tip was being trapped by the lesion.That stress was assumed to have caused the tip to become separated; however, causation of tip separation could not be determined.The instructions for use (ifu) states: [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 a corsair pro catheter became separated during a pci.8fr long femoral sheaths were placed in bilateral, 8fr al.75 guide was placed in the rca, and 8fr ebu 3.5 was placed in the lad.The rca was wired with a pilot 200 guide wire followed by the corsair pro.The corsair pro was advanced twisting as per ifu.At mid to distal section of the rca while twisting the distal radiopaque end of the corsair pro broke off from the rest of the corsair pro.Attempts were made with balloons to pre-dilate the rca to advance a snare down.Unfortunately neither the balloons nor the snare were able to advance to the dislodged corsair pro tip.While trying to snare, the snare kinked the pilot 200 causing loss of placement of the wire.Antegrade aborted and attempted to go retrograde, however, failed as there were no collateral options.The separated tip was left in situ.The patient was fine without injury or complication.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in 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 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI CORSAIR PRO
• 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: 8183443
• Report Number: 3003775027-2018-00223
• Device Sequence Number: 1987157
• Product Code: DQY
• UDI-Device Identifier: 04547327111850
• UDI-Public: (01)04547327111850(17)210228(10)180324K041
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161126
• 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): 12/13/2018
• Report Date (Section F): 12/13/2018

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CSR150-26P
• Device Lot Number: 180324K041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 12/20/2019
• 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
• Patient Age: 63 YR