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

Model Number CH08-40-75US

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, while removing the 8-mm balloon after doing an upper arm stenosis wherein the lesion was effaced, resistance was noted. The physician continued to pull (excessive force was not applied) and the balloon broke off at the proximal end of the third port infusion site just proximal to the balloon. It was stated that half of the device was in the physician's hands and the other half was stuck in the 6f medical sheath (from a competitor's) used. It was also stated that occlusion was felt while pulling the balloon through the 6f sheath. It was also noted that the physician initially utilized a 5-mm balloon for a juxta anastomosis which was successful. There was nothing unusual observed on the device prior to use. The catheter was not repaired, there was no leak, and no luer adapter issue. The insertion site was treated prior to product placement. It was noted that flushing was performed prior to insertion, and the balloon and the third port worked properly. There was no patient injury.

• Brand Name: CHAMELEON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): AV MEDICAL TECHNOLOGIES; 21 habarzel street; tel-aviv 67770 16; 6777016
• Manufacturer (Section G): AV MEDICAL TECHNOLOGIES; 21 habarzel street; tel-aviv 67770 16; 6777016
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10123997
• MDR Text Key: 200848918
• Report Number: 3011144059-2020-00001
• 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
• Report Date: 06/05/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CH08-40-75US
• Device Catalogue Number: CH08-40-75US
• Device Lot Number: 21900362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial