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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received. The device was not returned, but a photo was available for evaluation. Visual inspection noted a chameleon catheter with the balloon disengaged from the catheter at the infusion exit port. The device showed no evidence of use. It was reported that there was detachment of the balloon. The reported issue was confirmed. The most likely cause could not be established from the information available. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during procedure, the technician was removing the protective sleeve and when gently pulling, the balloon pulled off and broke completely (no excessive force was used). It was said that the balloon was detached from the shaft and the catheter was unable to be used in the procedure. No damage was noted on the device packaging. The box that the device came in was intact. The catheter was not repaired and had no leak. No cleaning agent was used on the device. There was no luer adapter issue. A standard prep technique was done on the insertion site prior to product placement. There was no blood loss and no blood transfusion was required. No medical intervention/treatment was provided due to the event. The catheter was replaced with the same lot number on the same date as soon as the balloon broke. The said replacement resolved the issue and the procedure was completed but that balloon also broke at the end of the case which was reported separately. 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
IS 6777016
Manufacturer (Section G)
AV MEDICAL TECHNOLOGIES
21 habarzel street
tel-aviv 67770 16
IS 6777016
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key12787549
MDR Text Key281517021
Report Number3011144059-2021-00006
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/02/2022
Device Model NumberCH08-40-75US
Device Catalogue NumberCH08-40-75US
Device Lot Number22001417
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
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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