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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 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was no damage noted to the balloon, but when the balloon was prepared, and the protective sheath was pulled off of the catheter prior to the procedure or prior to using on the patient, the balloon detached from the catheter shaft; the product was no longer used. The physician used another product (entire unit) from the same manufacturer to complete the procedure. There was no damage to the device's box and packaging. The product/kit was still sealed upon receipt. There was no excessive force used to pull/take out the product. There was nothing unusual observed on the device prior to use, and flushing was not done. There were no other products being utilized with the device, and there were no other defects/damages found on the product. There was no blood loss, and blood transfusion was not required. There was no intervention/treatment required as a result of the event. There was no 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 Key10731679
MDR Text Key213001525
Report Number3011144059-2020-00007
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 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
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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