MAUDE Adverse Event Report: AV MEDICAL TECHNOLOGIES CHAMELEON; CATHETER, CONTINUOUS FLUSH

Model Number CH10-40-75US

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

According to the reporter, the patient was presented with a narrowing in upper portion of brachial vein medial to a covered stent.The doctor gained initial access via a micro puncture set, where the doctor then placed an angiocath for initial imaging.Proper flushing performed of sheath, guidewire, and catheter prior to case with normal result.Once the lesion was imaged, a 7fr (french) competitor¿s sheath was introduced over the wire followed by a 10x40 chameleon balloon.The balloon was advanced to the area of stenosis and inflated to rbp (rated burst pressure) of 14.Balloon was then retracted to the area at the medial endpoint of the stent and angioplasty was performed in a second area using inflation device to the rbp.Balloon was deflated after 60 seconds, and imaging was performed to determine that there was no residual stenosis post angioplasty.The doctor went to remove the balloon and as the doctor pulled through the sheath, the doctor received resistance.The doctor was able to pull again but the resistance increased and at this point, the doctor knew that at least a portion of the balloon was inside the sheath.The doctor pulled again, and the balloon separated from the catheter proximal to the port.The doctor removed the sheath and the balloon remained inside.The balloon was stuck inside the sheath, and both were removed simultaneously over the wire.Sheath was removed with balloon inside as the remedial action and the procedure was completed after another sheath was reintroduced and imaging was done to ensure no remaining debris or residual damage was done.Detachment was spontaneous.The device passed through a previously deployed stent.There was nothing unusual observed on the device prior to use.There were no other products being utilized with the device.Cleaning agent was not used on the device.The product was not replaced because it was a sample product.There was no adverse event and the patient recovered normally.There was an estimated blood loss of 5 cc (cubic centimeters), but no blood transfusion was performed.There was no intervention needed and no medical intervention was needed as a result of the product failure.There was no reported patient injury.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHAMELEON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18503897
• MDR Text Key: 333329483
• Report Number: 3011144059-2024-00001
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10884521812314
• UDI-Public: 10884521812314
• 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: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH10-40-75US
• Device Catalogue Number: CH10-40-75US
• Device Lot Number: 22301300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1