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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. Three photos were received. Photographic evaluation noted the balloon had disengaged from the catheter. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications. The reported condition was confirmed. The most likely cause could not be established from the information available. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, after several inflations, at the end of the procedure, when the catheter was being removed from the patient, the catheter sheared off while being removed from the 6 french merit sheath (no excessive force used). They were able to retrieve the entire balloon as it was stuck inside of the sheath - balloon completely broken off from the catheter shaft. Kelly clamp was used to retrieve the detached item with no additional medical intervention required in retrieving. Nothing unusual was observed prior to use. The catheter was not repaired and had no leak. There was no luer adapter issue. No cleaning agent was used on the device. Usual prep was done on the insertion site prior to product placement. 6 french merit sheath and. 035 guidewire were being utilized with the device. Flushing was performed per ifu (instruction for use) with no issues identified. The balloon was inflated with an inflation device. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device and no excessive force was used. It was said that the catheter was inside the patient¿s body, so that was why there was blood. It was said that there was an unknown amount of blood loss. No blood transfusion was required. No medical intervention/treatment provided to the patient due to the event. It was said that they did not pull out another one to resolve the issue since it was at the end of the procedure. The procedure was still completed despite of the issue - they were finished with the inflations. 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 Key12868198
MDR Text Key283111225
Report Number3011144059-2021-00007
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/28/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
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 Received12/08/2021
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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