MAUDE Adverse Event Report: AV MEDICAL TECHNOLOGIES CHAMELEON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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.

• Brand Name: CHAMELEON
• Type of Device: CATHETER, 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 Key: 12546603
• MDR Text Key: 273777970
• Report Number: 3011144059-2021-00002
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170635
• Number of Events Reported: 1
• 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 Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CH12-40-75US
• Device Catalogue Number: CH12-40-75US
• Device Lot Number: 22100320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/04/2021
• 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