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

Catalog Number	CRV135-19P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: 3009121749 device evaluation could not be performed because the affected device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the provided information and referring to know similar events, it was presumed that tensile stress generated with manipulation had likely contributed to tip separation of the reported caravel microcatheter.The applied stress would exceed the product design limit and therefore damage the tip when the tip was being caught and restricted its movement by the complicated 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.) [malfunctions and adverse effects] ~ separation.
Event or Problem Description
Sus voluntary event report number: mw5096830 was received from the us distributor.It was reported as follows: retained microcatheter "9/" md using an asahi caravel microcatheter during pci of a chronic total occlusion.As he pulled back, the tip of the catheter dislodged mid rca and was unable to be retrieved.It was felt that the right lesion was the cause, not a faulty product.Complication was discussed with patient.

• Brand Name: 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: 11043307
• Report Number: 3003775027-2020-00207
• Device Sequence Number: 1256481
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)221031(10)191104K03A
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 10/31/2022
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 191104K03A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/20/2020
• 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