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 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received. The device was not returned, but a photo was available for evaluation. Visual inspection noted a chameleon catheter with the balloon disengaged from the catheter at the infusion exit port. The device showed no evidence of use. It was reported that there was detachment of the balloon. The reported issue was confirmed. The most likely cause could not be established from the information available. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, the technician was removing the protective sleeve and when gently pulling, the balloon pulled off and broke completely (no excessive force was used). It was said that the balloon was detached from the shaft and the catheter was unable to be used in the procedure. No damage was noted on the device packaging. The box that the device came in was intact. The catheter was not repaired and had no leak. No cleaning agent was used on the device. There was no luer adapter issue. A standard prep technique was done on the insertion site prior to product placement. There was no blood loss and no blood transfusion was required. No medical intervention/treatment was provided due to the event. The catheter was replaced with the same lot number on the same date as soon as the balloon broke. The said replacement resolved the issue and the procedure was completed but that balloon also broke at the end of the case which was reported separately. There was no reported 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12787549
• MDR Text Key: 281517021
• Report Number: 3011144059-2021-00006
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/10/2021
• 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: 10/26/2021
• 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