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

Catalog Number	CRV150-19P
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc (thailand) co., ltd., (b)(4).Exemption #e2015028.Attempts were made to gather thorough event information during complaint processing; no further information could be obtained.Device investigation could not be conducted as the caravel catheter was unavailable.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.It was presumed that pulling force exceeding the product's design limit might be inadvertently applied to the catheter while the tip was trapped by the heavily calcified lesion causing damage to the tip.The tip was assumed to be separated by pulling force applied during catheter removal.Although 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.Instructions for use states: [contraindications] do not use this microcatheter in advanced calcified lesion; [warnings] if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulation, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damages to this microcatheter and damage the blood vessel.); and, [malfunctions and adverse effects] separation.
Event or Problem Description
It was reported that the pci was to treat a heavily calcified lesion in the proximal to mid lad.An asahi wire was able to advance through the lesion.The lad was very tortuous and at the mid section was heavily calcified.A non-asahi penetration catheter was used.The lesion was so tight that it made the catheter kinked.It was needed to exchange out the guide wire to another wire in order to do atherectomy, so that the catheter was changed to the subject catheter.The catheter was advanced through the lesion by pushing.It went across the lesion.Then the guide wire was switched out for an atherectomy wire.When the catheter was pulled back through the heavily calcified lesion, it was noticed that the tip separated from the shaft of the catheter.Unfortunately the atherectomy device was needed and when the guide wire was pulled back some, the separated tip came off the wire and floated down into a septal perforator.Procedure took over 4.5 hours at that time, plus the patient was (b)(6), the physician decided to make no attempt to get the separated tip out of the patient.

• Brand Name: ASAHI CARAVEL
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 6992595
• Report Number: 3003775027-2017-00198
• Device Sequence Number: 1850855
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)200229(10)170313K301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2017
• Report Date (Section F): 10/19/2017

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: 02/29/2020
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 170313K301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/01/2017
• 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 Weight: 191