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

Catalog Number CSR135-26PR

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).When the device was returned to the manufacturer, a reportable malfunction was recognized for the first time; therefore, the date of this report and the date received by the manufacturer were considered the date the device returned.The corsair pro microcatheter was returned for evaluation.The tip of the microcatheter was scratched likely by calcium of the lesion.The polymer jacket on the shaft proximal to the tip was also scratched and partially peeled off.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 strong friction with the calcified lesion during catheter manipulation had most likely contributed to the observed damage on the surface of the tip and the distal shaft of the returned microcatheter.It was concluded that this event was not attributed to product quality.Although there were no adverse patient effects, damage on the polymer jacket was severe; therefore, it was unable to completely rule out potentiality that some fragment(s) could be left in the patient.The instructions for use (ifu) states: [warnings] do not use this microcatheter in advanced calcified lesion; [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] damage.

Event Description

It was reported that the tip of an asahi corsair pro microcatheter broke during a pci to treat a heavily calcified cto in the lad #7.The microcatheter became stuck in the lesion during manipulation, and therefore, it was difficult to remove it.When it was finally removed from the lesion, the tip was found damaged.A new corsair pro was replaced to successfully complete recanalization by stenting.There were no adverse patient effects after the procedure.

• 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: 10458048
• MDR Text Key: 204619968
• Report Number: 3003775027-2020-00131
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327132084
• UDI-Public: (01)04547327132084(17)230331(10)200416K071
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171933
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CSR135-26PR
• Device Lot Number: 200416K071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2020
• 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): Other