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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASAHI INTECC ASAHI CARAVEL; CATHETER
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ASAHI INTECC ASAHI CARAVEL; CATHETER Back to Search Results
Model Number CRV135-19P
Device Problem Separation Problem (4043)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2019
Event Type  malfunction  
Event Description
While trying to push the catheter through the lesion it became stuck.Upon withdrawing from lesion about 2mm of the tip was separated from the rest of the catheter but remained on the wire.The doctor was able to remove the catheter and the wire at the same time.While wire position was lost the entire wire/device was removed and no particulate left in the patient.Patient was fine with no adverse patient event.The physician stated he did not think the product was defective but rather a very difficult lesion to treat.Wanted to bring awareness of the event and will continue to use the device.
 
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Brand Name
ASAHI CARAVEL
Type of Device
CATHETER
Manufacturer (Section D)
ASAHI INTECC
3-100 akatsuki-cho
seto, 489-0 071
JA  489-0071
MDR Report Key8783326
MDR Text Key150972634
Report Number3004718255-2019-00004
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/11/2019,07/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model NumberCRV135-19P
Device Catalogue NumberCRV135-19P
Device Lot Number190315K03A
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/11/2019
Distributor Facility Aware Date07/08/2019
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer07/11/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight31
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