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

Catalog Number CSW135-26N

Device Problem Entrapment of Device (1212)

Patient Problem Extravasation (1842)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2016, asahi intecc obtained information regarding the device issue.Several attempts were made to obtain complete event information; however, no additional information other than pericardial effusion was obtained.On (b)(6) 2016, asahi intecc became aware of this pericardial effusion; therefore, date of awareness is considered to be (b)(6) 2016.Since there was no information regarding how pericardial effusion was occurred and how it was treated, it was possible that perforation of a vessel could have occurred.If so, it could not be denied that the asahi catheter might have contributed perforation.The non-asahi wire was inserted into the asahi catheter when the devices were returned for manufacturer investigation.An attempt was made to remove the wire from the catheter but the devices could not be separated.In the observation of the returned asahi catheter, wavy deformation which can be typically seen on a used catheter was found on the distal shaft.The tip surface was rugged and there were scratch marks which can be typically seen after use.Near the proximal end of the asahi catheter, there observed unraveled strands of the shaft suggesting excessive rotational force was accumulated on that spot.The distal tip was observed under x-ray.It revealed the non-asahi wire formed several knots of the coils inside the asahi catheter.Locations of coil knots were found to be overlapped with rugged surface of the catheter tip.These findings suggested that suck between the devices was caused due to deformation of the non-asahi wire.Stretching of the asahi catheter was observed during procedure; however, no elongation was observed on the returned asahi catheter.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the information provided and the investigation outcome, stuck occurred between the asahi catheter and the non-asahi wire was due to deformation of the non-asahi wire.It is presumed that one-directional rotational force exceeding the product design limit might have contributed to deformation of the coils of the non-asahi wire as well as unraveling of the strands of the asahi catheter.Therefore, excessive rotational force applied during device manipulation was thought to be causation of possible perforation.Damages caused by excessive rotational force were seen on both devices and it could not be identified whether which device triggered possible perforation.Ifu states that: 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.).

Event Description

Reportedly, a non-asahi wire crossed a lesion in the proximal under a support of a non-asahi support catheter.An asahi catheter was advanced over the non-asahi wire for passing the lesion and facilitating wire exchange from the wire to a softer wire.The asahi catheter could not fully advance on the wire and the devices got stuck together.When the operators tried to remove the catheter and leave the wire in place, it caused stretching of the catheter, and whole system was removed.The patient experienced pericardial effusion and discharged after some treatment.

• Brand Name: ASAHI CORSAIR MICROCATHETER
• Type of Device: MICRO 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 ; 561485551
• MDR Report Key: 6188025
• MDR Text Key: 62788391
• Report Number: 3003775027-2016-00214
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K083127
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CSW135-26N
• Device Lot Number: 160418K021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2016
• 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