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

Model Number CH08-40-75US

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the scrub tech was removing the protective sleeve from the catheter and it got stuck on the shaft and when the tech was pulling it off, it ripped/broke the catheter shaft distal end into two. The doctor had switched to competitor's balloon. 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; IS 6777016
• Manufacturer (Section G): AV MEDICAL TECHNOLOGIES; 21 habarzel street; tel-aviv 67770 16; IS 6777016
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder,co, CO 80301 ; 3035306409
• MDR Report Key: 12551222
• MDR Text Key: 281608551
• Report Number: 3011144059-2021-00003
• 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

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2022
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/02/2022
• Device Model Number: CH08-40-75US
• Device Catalogue Number: CH08-40-75US
• Device Lot Number: 22001417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• 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