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

Model Number	CH06-40-75US
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, when the contrast medium was injected through the injection port, the contrast medium leaked from a portion other than the drainage hole.There was a leak at the catheter shaft.There was no luer adapter problem.There was nothing unusual observed on the device prior to use.There was no resistance encountered when advancing the device.Tego was not utilized, and the insertion site was not handled prior to product placement.Intervention/treatment was not required as a result of the event.As a remedial action the catheter was removed and replaced.The procedure was completed.The patient did not have any symptoms or complications related to this event.There was no blood loss and blood transfusion was not required due to the event.Mozarc performed an evaluation of the reported catheter and the initial evaluation of the incident device found that visual inspection of the device noted that there was a crack on the luer port for the contrast media.The crack leaked when the port was flushed with water.The packaging was not returned, so the root cause of the observed damage could not be reliably determined, however all devices are tested for le aks before packaging so the cause is unlikely to be manufacturing related.The reported condition was confirmed.There was no reported patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that there was a crack on the luer port for the contrast media.The crack leaked when the port was flushed with water.It was reported that there was leakage in the middle of the shaft.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.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
• 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: 17402805
• Report Number: 3011144059-2023-00006
• Device Sequence Number: 20323995
• Product Code: KRA
• UDI-Device Identifier: 10884521812277
• UDI-Public: 10884521812277
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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 Model Number: CH06-40-75US
• Device Catalogue Number: CH06-40-75US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/27/2023
• 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 Sex: Unknown