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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV MEDICAL TECHNOLOGIES CHAMELEON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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AV MEDICAL TECHNOLOGIES CHAMELEON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number CH08-40-75US
Device Problem Device Fell (4014)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2020
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 the inflation of the balloon, it dislodged from the catheter. They were able to retrieve the balloon without any incident to the patient. It was also stated that the balloon was stuck in the sheath of post removal from the patient and they had to have an additional stick for sheath access on the patient. The catheter was not repaired, there was no leak, saline was used as cleaning agent on the device, tego was not utilized, there was no luer adapter issue, there was no any patient symptoms or complications associated with this event and the insertion site was treated prior to product placement. Excessive force was not used, snare was used to grab the detached balloon, there was no any defects noted on the device, there was an occlusion and there was no packaging damage that might have contributed to the reported issue. A new device was used to resolve the issue and it was used successfully. Nothing unusual was observed on the device prior to use, flushing was performed, there were no other products being u tilized with the device, there was no blood loss, blood transfusion was not needed and there was no medical intervention done to the patient. There was no reported patient injury.
 
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Brand NameCHAMELEON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
Manufacturer (Section G)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key10351401
MDR Text Key203120849
Report Number3011144059-2020-00006
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberCH08-40-75US
Device Catalogue NumberCH08-40-75US
Device Lot Number21903676
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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