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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the inflation of the balloon, it dislodged from the catheter.They were able to retrieve the balloon without any incident to the patient.It was also stated that the balloon was stuck in the sheath of post removal from the patient and they had to have an additional stick for sheath access on the patient.The catheter was not repaired, there was no leak, saline was used as cleaning agent on the device, tego was not utilized, there was no luer adapter issue, there was no any patient symptoms or complications associated with this event and the insertion site was treated prior to product placement.Excessive force was not used, snare was used to grab the detached balloon, there was no any defects noted on the device, there was an occlusion and there was no packaging damage that might have contributed to the reported issue.A new device was used to resolve the issue and it was used successfully.Nothing unusual was observed on the device prior to use, flushing was performed, there were no other products being u tilized with the device, there was no blood loss, blood transfusion was not needed and there was no medical intervention done to the patient.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, g4.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, during the inflation of the balloon, it dislodged from the catheter.They were able to retrieve the balloon without any incident to the patient.It was also stated that the balloon was stuck in the sheath of post removal from the patient and they had to have an additional stick for sheath access on the patient.The catheter was not repaired; there was no leak; saline was used as cleaning agent on the device; tego was not utilized; there was no luer adapter issue; and there was no any patient symptoms or complications associated with this event and the insertion site was treated prior to product placement.Excessive force was not used.There were no any defects noted on the device.There was an occlusion and there was no packaging damage that might have contributed to the reported issue.A new device was used to resolve the issue and it was used successfully.Nothing unusual was observed on the device prior to us.Flushing was performed.There were no other products being utilized with the device.There was no blood loss.Blood transfusion was not needed and there was no medical intervention done to the patient.The insertion site was treated with chloroprep prior to product placement and a snare was used to grab the detached balloon/retrieved the tip of the balloon.There was no reported patient injury.

Event Description

According to the reporter, during the inflation of the balloon, it dislodged from the catheter.They were able to retrieve the balloon without any incident to the patient.It was also stated that the balloon was stuck in the sheath of post removal from the patient and they had to have an additional stick for sheath access on the patient.There were no other defects noted on the device.There was an occlusion and there was no packaging damage that might have contributed to the reported issue.A new device was used to resolve the issue and it was used successfully.Nothing unusual was observed on the device prior to use.Flushing was performed.There were no other products being utilized with the device.There was no blood loss.Blood transfusion was not needed and there was no medical intervention done to the patient.The insertion site was treated with chloroprep prior to product placement and a snare was used to grab the detached balloon/retrieved the tip of the balloon.The catheter was not repaired, there was no leak, saline was used as a cleaning agent on the device, tego was not utilized, there was no luer adapter issue, there was no any patient symptoms or complications associated with this event and excessive force was not used.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.

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
• Manufacturer (Section G): AV MEDICAL TECHNOLOGIES; 21 habarzel street; tel-aviv 67770 16
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 10351401
• MDR Text Key: 203120849
• Report Number: 3011144059-2020-00006
• Device Sequence Number: 1
• Product Code: LIT
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: CH08-40-75US
• Device Catalogue Number: CH08-40-75US
• Device Lot Number: 21903676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female