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. Three photos were received. Photographic evaluation noted the balloon had disengaged from the catheter. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications. The reported condition was confirmed. The most likely cause could not be established from the information available. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after several inflations, at the end of the procedure, when the catheter was being removed from the patient, the catheter sheared off while being removed from the 6 french merit sheath (no excessive force used). They were able to retrieve the entire balloon as it was stuck inside of the sheath - balloon completely broken off from the catheter shaft. Kelly clamp was used to retrieve the detached item with no additional medical intervention required in retrieving. Nothing unusual was observed prior to use. The catheter was not repaired and had no leak. There was no luer adapter issue. No cleaning agent was used on the device. Usual prep was done on the insertion site prior to product placement. 6 french merit sheath and. 035 guidewire were being utilized with the device. Flushing was performed per ifu (instruction for use) with no issues identified. The balloon was inflated with an inflation device. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device and no excessive force was used. It was said that the catheter was inside the patient¿s body, so that was why there was blood. It was said that there was an unknown amount of blood loss. No blood transfusion was required. No medical intervention/treatment provided to the patient due to the event. It was said that they did not pull out another one to resolve the issue since it was at the end of the procedure. The procedure was still completed despite of the issue - they were finished with the inflations. 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: 12868198
• MDR Text Key: 283111225
• Report Number: 3011144059-2021-00007
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 11/24/2021
• 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: 12/08/2021
• 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