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

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.

• Brand Name: CHAMELEON
• Type of Device: CATHETER, 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 Key: 10731679
• MDR Text Key: 213001525
• Report Number: 3011144059-2020-00007
• 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,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Model Number: CH08-40-75US
• Device Catalogue Number: CH08-40-75US
• Device Lot Number: 21903676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/02/2021
• 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