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

Model Number CH08-40-75US

Device Problems Detachment of Device or Device Component (2907); 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.

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.

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 and the inflation fluid used were contrast and saline solution.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.

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: 12868198
• MDR Text Key: 283111225
• Report Number: 3011144059-2021-00007
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 07290016745047
• UDI-Public: 07290016745047
• 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,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• 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: 02/27/2023
• 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
• Patient Sequence Number: 1