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

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 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be determined because the product lot number information was not available.Device evaluation could not be performed because the device was discarded by the facility.Investigation of production records could not be performed because lot information was unavailable.Although lot history record review could not be performed, all the shipped products were inspected in the production process for meeting the product specifications and release criteria; therefore, it was concluded there was no indication of product deficiency.The obtained information inferred that the tip of the corsair pro was being trapped by the existing stents when it was removed; therefore, the applied pulling stress exceeded the product design limit and made the tip to separate.It was concluded that this event was not attributed to product quality.The obtained information also inferred that the corsair pro had not caused or contributed to the reported separation of the non-asahi guide wire that was likely attributed to the existing stents.Instructions for use (ifu) states: [warnings] do not use this microcatheter in lesions through strut of stent; [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 Description

It was reported that the tip of an asahi corsair pro microcatheter separated during a pci to treat a mildly torturous, moderately calcified 90-99% occlusion in the lad.During the procedure a non-asahi runthrough guide wire became trapped in a stent strut.The physician inserted the corsair pro in hopes of freeing the tip of the wire.When the corsair pro was removed, its tip was sheared off in the distal lad.He stated he felt that it got caught on a stent strut when he went to remove the corsair after realizing the tip of the wire was not freed.He then attempted to remove the runthrough wire again- at that time the spring coil of the wire unraveled from the distal lad, to lm into the aorta.The tip was in the distal lad flow was still established at the end of the procedure.No attempts were made to retrieve due to it being so distal in the vessel.The patient was transferred to another hospital for removal of the guide wire and expected to be discharged home in a day or two.

• Brand Name: CORSAIR PRO
• 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: 10330316
• MDR Text Key: 200643023
• Report Number: 3003775027-2020-00114
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR