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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV MEDICAL TECHNOLOGIES CHAMELEON CATHETER, CONTINUOUS FLUSH

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AV MEDICAL TECHNOLOGIES CHAMELEON CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number CH09-40-75US
Device Problems Burst Container or Vessel (1074); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during procedure, the physician inflated the balloon in cephalic arch using two syringe method and saline as inflation fluid, 1-2 times of inflation, the balloon burst longitudinally. Upon trying to remove the balloon from sheath (compet itor¿s brand), the balloon got caught in sheath, and when caught, it snapped spontaneously just proximal of balloon injection port (3rd port). The balloon remained snapped off and stuck in sheath. It did not cause any vessel trauma. Upon removal of 7fr sheath, they were able to pull the balloon out of sheath for further inspection. All fragments of the balloon were retrieved. No additional medical intervention required to retrieve the detached item. The flushing was performed per the ifu (instructions for use). Nothing unusual observed on the device prior to use. No other products being utilized with the device. No other defects/damages found on the product. They used a. 035 guide wire. The device did not pass through a previously deployed stent. No resistance encountered when advancing the device and no excessive force used. There was no kink on the shaft. The catheter was not repaired. There was no leak. Tego was not utilized. No cleaning agent used on the device. There was no blood loss and blood transfusion was not required. The product was replaced with the same brand on the day of the event. The procedure was not completed. There was no patient injury.
 
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Brand NameCHAMELEON
Type of DeviceCATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
IS 6777016
Manufacturer (Section G)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
IS 6777016
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key11930431
MDR Text Key254026884
Report Number3011144059-2021-00001
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170635
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2022
Device Model NumberCH09-40-75US
Device Catalogue NumberCH09-40-75US
Device Lot Number22000703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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