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

Catalog Number CRV135-19P

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: (b)(4), registration number: (b)(4).The affected device has returned for evaluation.Investigation results will be reported in the follow-up report.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Due to limited provided information and the affected device was yet to returned, it was unable to determine the root cause.Referring to know similar events, it was presumed that stress generated with catheter manipulation had caused the reported tip separation.The applied stress would localize and therefore exceed the product's design limit likely when the tip was being caught by the lesion.It was concluded that this event was not attributed to product quality.No capa will be taken.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 Description

It was reported that the tip of an asahi caravel microcatheter separated during a procedure.The tip fragment retained in the patient.The patient discharged.

Manufacturer Narrative

Manufacturing site: asahi intecc (thailand) co., ltd., pathum thani, thailand, registration number: 3003780911.The reported caravel microcatheter was returned for evaluation.Tip separation was confirmed at the junction of catheter shaft and tip.The entire tip was missing.Microscopic observation revealed that there were scratches on the catheter shaft proximal to the torn end of the tip which was likely caused by contacting calcium.Stretching of the distal end of braid tube and inner jacket was observed.Stretching was observed on the entire perimeter, indicating the tip was torn by tensile stress.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 investigation outcome, it was presumed that stress generated with catheter manipulation had caused the reported tip separation.The applied stress would localize and therefore exceed the product's design limit likely when the tip was being caught by the lesion.It was concluded that this event was not attributed to product quality.No capa will be taken.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.

• Brand Name: CARAVEL
• Type of Device: PERCUTANEOUS 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
• MDR Report Key: 16030402
• MDR Text Key: 305975443
• Report Number: 3003775027-2022-00170
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 220803K111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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): Disability