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

Catalog Number	CRV150-19P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Device investigation could not be performed because the device was not returned.Lot history review revealed no anomaly relating to the reported event.There is one similar event (mfr report #: 3003775027-2019-00203) reported from this lot.The similar event was likely attributed to anatomy and manipulation technique.Therefore, it was concluded there was no indication of product deficiency.Based on the provided information and referring to known similar events, it was presumed that tensile stress generated with catheter removal had most likely contributed to the reported tip separation.The tensile stress would exceed the product design limit when the tip movement was restricted possibly by calcified segment of the target lesion.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [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 manipulations, 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 damage to this microcatheter and damage the blood vessel.); and, [malfunction and adverse effects] separation.
Event or Problem Description
Uf report #: (b)(4) was received.It was reported that the tip of caravel microcatheter broke off into the patient's rca and eventually drifted into a side branch leading to minimal concern.

• Brand Name: ASAHI CARAVEL
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 9630463
• Report Number: 3003775027-2020-00015
• Device Sequence Number: 11353262
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)220331(10)190403K10A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 190403K10A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/26/2020
• 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: 55 YR