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U.S. Department of Health and Human Services

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

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AV MEDICAL TECHNOLOGIES CHAMELEON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number CH12-40-75US
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the 12 mm balloon broke off just above the side port during an angioplasty procedure on the patient's dialysis access. It was stated that the catheter was not repaired, there was no leak, tego was not utilized and there was no luer adapter issue. It was also mentioned that no cleaning agent was used. There was no reported patient injury.
 
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Brand NameCHAMELEON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
6777016
Manufacturer (Section G)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
6777016
Manufacturer Contact
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key10124010
MDR Text Key199092237
Report Number3011144059-2020-00002
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
Report Date 06/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
Device Model NumberCH12-40-75US
Device Catalogue NumberCH12-40-75US
Device Lot Number21803155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated by Manufacturer? No
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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