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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 CH08-40-75US
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, while removing the 8-mm balloon after doing an upper arm stenosis wherein the lesion was effaced, resistance was noted. The physician continued to pull (excessive force was not applied) and the balloon broke off at the proximal end of the third port infusion site just proximal to the balloon. It was stated that half of the device was in the physician's hands and the other half was stuck in the 6f medical sheath (from a competitor's) used. It was also stated that occlusion was felt while pulling the balloon through the 6f sheath. It was also noted that the physician initially utilized a 5-mm balloon for a juxta anastomosis which was successful. There was nothing unusual observed on the device prior to use. The catheter was not repaired, there was no leak, and no luer adapter issue. The insertion site was treated prior to product placement. It was noted that flushing was performed prior to insertion, and the balloon and the third port worked properly. There was no 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 Key10123997
MDR Text Key200848918
Report Number3011144059-2020-00001
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,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 Model NumberCH08-40-75US
Device Catalogue NumberCH08-40-75US
Device Lot Number21900362
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 Received11/11/2019
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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