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

Model Number CH07-40-75US

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Detachment of Device or Device Component (2907); Positioning Problem (3009); Device Fell (4014)

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

Event Date 12/17/2021

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 procedure, a 7mm balloon was inserted through 7fr.(french 7) sheath into mid basilic vein and inflated to 22 atm of pressure per ifu (instruction for use).The balloon was inflated using an inflation device and the inflation fluid used was contrast and saline 50-50 mix.The balloon burst during first inflation and leak was noted.The physician visualized the contrast solution leaving the balloon under fluoroscopy.The doctor stated that he had difficulty removing the balloon from the patient.He removed the 7fr.(french 7) sheath and still had difficulty removing the ruptured balloon then eventually he was successful in removing the balloon.The balloon was removed simultaneously (in one action) with introducer sheath.All fragments were retrieved and it was mentioned that the catheter broke into 2 pieces when they were trying to remove it from the sheath.The catheter was not repaired.He used a boston scientific balloon to complete the procedure and to resolve the patient stenosis.There was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was treated with chlorhexidine solution prior to product placement.Flushing was performed with no issues.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.No excessive force was used.There was no significant blood loss and blood transfusion was not required.There was no intervention/treatment required as a result of the event.There was no reported patient injury.

Event Description

According to the reporter, during procedure, a 7mm balloon was inserted through 7fr.(french 7) sheath into mid basilic vein and inflated to 22 atm of pressure per ifu (instruction for use).The balloon was inflated using an inflation device and the inflation fluid used was contrast and saline 50-50 mix.The balloon burst during first inflation and leak was noted.The direction of the balloon burst was unknown.The physician visualized the contrast solution leaving the balloon under fluoroscopy.The doctor stated that he had difficulty removing the balloon from the patient.He removed the 7fr.(french 7) sheath and still had difficulty removing the ruptured balloon then eventually he was successful in removing the balloon.Balloon was removed simultaneously (in one action) with introducer sheath.All fragments were retrieved and it was mentioned that the catheter broke into 2 pieces when they were trying to remove it from the sheath.The catheter was not repaired.He used a boston scientific balloon to complete the procedure and to resolve the patient stenosis.There was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was treated with chlorhexidine solution prior to product placement.Flushing was performed with no issues.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.No excessive force was used.There was no significant blood loss and blood transfusion was not required.There was no intervention/treatment required as a result of the event.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

Additional information: b5, g3 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 procedure, a 7mm balloon was inserted through 7fr.(french 7) sheath into mid basilic vein and inflated to 22 atm of pressure per ifu (instruction for use).The balloon was inflated using an inflation device and the inflation fluid used was contrast and saline 50-50 mix.The balloon burst during first inflation and leak was noted.The direction of the balloon burst was unknown.The physician visualized the contrast solution leaving the balloon under fluoroscopy.The doctor stated that he had difficulty removing the balloon from the patient.He removed the 7fr.(french 7) sheath and still had difficulty removing the ruptured balloon then eventually he was successful in removing the balloon.Balloon was removed simultaneously (in one action) with introducer sheath.All fragments were retrieved and it was mentioned that the catheter broke into 2 pieces when they were trying to remove it from the sheath.The catheter shaft broke in the middle where the balloon was originally located (mid balloon).The catheter was not repaired.He used a boston scientific balloon to complete the procedure and to resolve the patient stenosis.There was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was treated with chlorhexidine solution prior to product placement.Flushing was performed with no issues.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.No excessive force was used.There was no significant blood loss and blood transfusion was not required.There was no intervention/treatment required as a result of the event.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

Additional information: g1,g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the balloon was detached from the catheter.Additionally, the internal part of the cannula within the balloon was broken into multiple pieces.It was reported that there was a balloon burst in an unknown direction, there was a balloon retrieval issue, and there was detachment of another component.The reported issues were 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.

Manufacturer Narrative

Additional information: g3 correction: h6 - secondary rfr code has been updated.(from detachment of other component to detachment of the balloon) 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, CO 55112 ; 7635265677
• MDR Report Key: 13177996
• MDR Text Key: 287351409
• Report Number: 3011144059-2022-00001
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 07290016745030
• UDI-Public: 07290016745030
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: CH07-40-75US
• Device Catalogue Number: CH07-40-75US
• Device Lot Number: 22002089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/06/2022; 01/24/2022; 05/17/2022; 09/29/2022; 06/06/2023
• Supplement Dates FDA Received: 01/24/2022; 02/08/2022; 06/02/2022; 10/06/2022; 06/21/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 56 KG