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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 CH12-40-75US
Device Problem Device Fell (4014)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/13/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during procedure, the balloon did not pass through a previously deployed stent; it was utilized with a 035 guide wire (bard), and resistance encountered when advancing it during first attempt. The balloon was inflated with syringe, no inflation fluid was used and it was deflated normally. After the anastomosis was cleared in the central artery, during removal/withdrawal of balloon/wire from the patient, excessive/additional force was used as there was some scare tissue in surrounding entrance site and the catheter broke/snapped at the side hole (exit port). This was a sheath less procedure. The doctor had to cut down and use snare to remove the balloon. No additional anesthesia required to perform the cutdown. Additional surgical time was needed. A diagnostic testing (fluoroscopy) was done as a part of procedure to verify if there were no parts retained on the patient¿s body. All pieces were accounted for and removed on the same day of the event. Nothing unusual observed on the device prior to use. The device was flushed with no issues identified. The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue. The insertion site was not treated with prior to product placement. Saline flush was the cleaning agent used on the device. There was no blood loss. Blood transfusion was not required. No additional medical treatments or medications. No hospital admission or prolonged hospitalization. The patient did not experience any symptoms and was in good condition.
 
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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 Key12546603
MDR Text Key273777970
Report Number3011144059-2021-00002
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,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCH12-40-75US
Device Catalogue NumberCH12-40-75US
Device Lot Number22100320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
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

Patient Treatment Data
Date Received: 09/29/2021 Patient Sequence Number: 1
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