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

Catalog Number CSW150-26N

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Subject catheter was returned with the concomitant guidewire which was inserted through the catheter, tip approx.23cm was extruded out from tip of the catheter.During processing of this complaint, attempts were made to obtain complete event.Only the brief information on the procedure could be obtained, no further details of the event was available.First date of the month of the date of awareness is quoted as the date of occurrence for reporting convenience.Observation of the devices revealed breakage of the tip polymer of the catheter due to clockwise rotational force given to the tip.Broken fragment was found attached on the guidewire that was inserted through.No other notable damage was observed with the devices, and the broken catheter was thought to be entire.Lot history review could not be conducted since no lot information was available.All the shipped products are inspected in the production process for meeting the product specifications and release criteria, there is no indication of a product deficiency.Based on the obtained information and the outcomes of the investigation, it is inferred that tip distal end of the catheter was exposed to some rotational abrasion force over the concomitant guidewire in the vessel, tip end was squeezed against the guidewire and finally broken apart on the guidewire.Ifu describes in the section of warning and precautions for use: do not rotate this microcatheter in the same direction, either clockwise or counterclockwise, for more than 10 consecutive rotations.If resistance is felt while rotating this microcatheter, do not proceed with further rotation regardless of the number of performed rotations.Identify the cause of resistance under fluoroscopy, and take an appropriate action.Never continue the operation without identifying the cause.(continuing rotation may damage or break apart this microcatheter or damage the blood vessels.) if any resistance is felt during the removal of this microcatheter, remove the microcatheter and the guide wire as a unit while checking under fluoroscopy the position of all the devices used in combination.

Event Description

For the procedure to unknown vessel unknown lesion, subject catheter was advanced by retrograde approach manner.During manipulation, physician felt that the catheter was sticky against the inserted guidewire, so that the devices were removed out from the anatomy.It was thought that the polymer is damaged.

• Brand Name: ASAHI CORSAIR MICROCATHETER
• Type of Device: MICRO CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 48900 71; JA 4890071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100, akatsuki-cho,; seto, 48900 71; JA 4890071
• Manufacturer Contact: eiichi kubo ; 3-100 akatsuki-cho,; seto, 48900-71 ; JA 4890071 ; 561485551
• MDR Report Key: 5308812
• MDR Text Key: 33831109
• Report Number: 3003775027-2015-00151
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00454732708797
• UDI-Public: 454732708797
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CSW150-26N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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