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

Model Number	CH07-40-75US
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a procedure on a patient with a stenosis in the launch area of the graft, the physician found resistance while injecting contrast media from the third port and removed the wire to complete the injection.When they reinserted the wire and tried to remove the catheter, the balloon was detached.They found it attached to the wire.The detachment was spontaneous.The catheter was not repaired.There was no leak.There was no luer adapter issue.The insertion site was not treated prior to product placement.No cleaning agent was used on the device.Nothing unusual was observed on the device prior to use.No other defects or damage were found on the product.An introducer sheath was used.A 0.035 guide wire was used.Flushing was not performed.No other products were being utilized with the device.The balloon was inflated with an inflation device.Saline and contrast were the inflation fluids used.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.No excessive force was used.The insertion site was not treated prior to product placement.A snare was used as an intervention to retrieve the balloon.They were able to successfully remove it from the patient on the same procedure.The physician used a competitor's balloon to complete the procedure, and the patient was safe.There was no blood loss.A blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one balloon attached to a guidewire, and one balloon not attached to a guidewire.In both photos, there were clear signs of use, and it was evident that the balloon was detached from the catheter.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.It was also reported that there was a fluid injection issue.The reported issue could not be 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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CHAMELEON
• Common Device Name: 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: 19917891
• Report Number: 3011144059-2024-00006
• Device Sequence Number: 12537260
• Product Code: KRA
• UDI-Device Identifier: 10884521812284
• UDI-Public: 10884521812284
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K170635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2024
• Device Model Number: CH07-40-75US
• Device Catalogue Number: CH07-40-75US
• Device Lot Number: 22201897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male