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

Catalog Number	CSR135-26P
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Single reporter exemption #e2015028.Importer received the user facility medwatch report (b)(4) on 04/14/2017 and forwarded it to the manufacturer on the same day.Device investigation could not be conducted as it was not available as of today.Two provided pictures showed that the microcatheter was separated at the base of the tip and the shaft was deformed due to continuous torsion.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Based on the provided information, it was presumed that rotational force exceeding the product's design limit might be inadvertently applied to the catheter while its tip had been trapped by the target lesion or the vasculature; however, the exact causation could not be identified as device analysis could not be conducted.Although actual device investigation could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of product deficiency.The ifu states: - [warnings] excess rotational load must not be applied if the microcatheter is bent.(the microcatheter may be damaged.); - [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.); - [warnings] always hold the connector with one hand and turn the microcatheter carefully while regularly releasing the accumulated torsion of the microcatheter.Never turn the microcatheter continuously while holding the connector with both hands or use any other means to apply force.When releasing the accumulated torsion, be sure to open the hemostatic valve on the y-connector.Do not turn the microcatheter in the same direction, either clockwise or counterclockwise, for more than 10 consecutive turns.(continuing rotation may damage or break the microcatheter or damage the blood vessels.In the worst case, life-threatening adverse events may occur.); and, - [malfunction and adverse effects] damage (separation, kink, bend, deforming, damage to the hydrophilic coating).
Event or Problem Description
During pci to treat a moderately calcified cto lesion, an asahi catheter was advanced to the septal collateral vessel.When the physician spun the catheter and pulled back, the catheter tip separated from the catheter shaft.Although attempted, retrieval of the tip fragment failed and the physician decided to treat the patient medically.The physician described the anatomy as "hostile".The patient had been fine with no health impacts.
Additional Manufacturer Narrative
Almost the entire tip of the returned catheter, approximately 7 mm in length, was missing.The strands on the distal shaft were disarranged due to excessive rotation and the shaft was bent.Based on the provided information and the investigation outcome, it was presumed that rotation in the same direction was continuously applied to the catheter while its tip was trapped by the target cto lesion.When the accumulated force exceeded the product design limit, it lead the catheter shaft to be deformed and the tip to be torn off; however, causation could not be ascertained.There was no indication of product deficiency.

• Brand Name: ASAHI CORSAIR PRO
• Common Device Name: MICRO CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 6528707
• Report Number: 3003775027-2017-00061
• Device Sequence Number: 19028056
• Product Code: DQY
• UDI-Device Identifier: 04547327111843
• UDI-Public: (01)04547327111843(17)191130(10)161129K011
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017
• Report Date (Section F): 04/07/2017

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: Physician
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CSR135-26P
• Device Lot Number: 161129K011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/15/2017
• 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: 61 YR