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

Model Number CH12-40-75US

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/25/2022

Event Type  malfunction  

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 angioplasy, the tech removed the balloon from the sheath and the back end of the split apart from the catheter.It was stated that the luer adapter detached (luer adapter and back end of the balloon came apart from the catheter).There was no leak.The insertion site treated with prior to product placement.Tego was not utilized and the catheter was not repaired.There was no patient symptoms or complications associated with this 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.

Event Description

According to the reporter, after angioplasy, when the tech removed the balloon/product through the sheath and the back end of the split apart from the catheter.It was stated that the balloon disconnected from the rest of the device/catheter.It was also stated that the balloon luer connector was detached (luer adapter came apart from the catheter).The detachment was spontaneous.There was no leak.The insertion site was treated prior to product placement.Flushing was performed per ifu (instruction for use) and there were no issues.The balloon was properly used and ifu (instruction for use) was followed, the device did not pass through a previously deployed stent, no resistance was encountered when advancing the device, resistance was encountered during the 1st attempt of pulling the device from sheath, no excessive force was used (during delivery or during withdrawal), tego was not utilized, introducer sheath was used (7 french, terumo) and the catheter was not repaired.The procedure was completed.There was no intervention/treatment required as a result of the event.There was no blood loss and blood transfusion was not required.There was no patient symptoms or complications associated with this event.There was no reported patient injury.

Event Description

According to the reporter, after angioplasy, when the tech removed the balloon/product through the sheath and the back end of the split apart from the catheter.It was stated that the balloon disconnected from the rest of the device/catheter.It was also stated that the balloon luer connector was detached (luer adapter came apart from the catheter).The detachment was spontaneous.There was no leak.The insertion site was treated prior to product placement.Flushing was performed per ifu (instruction for use) and there were no issues.The balloon was properly used and ifu (instruction for use) was followed, the balloon was deflated when removed, an inflation device used (inflation device make: bard, inflation device model: presto), the device did not pass through a previously deployed stent, no resistance was encountered when advancing the device, resistance was encountered during the 1st attempt of pulling the device from sheath, no excessive force was used (during delivery or during withdrawal), tego was not utilized, introducer sheath was used (7 french, terumo) and the catheter was not repaired.The procedure was completed.There was no intervention/treatment required as a result of the event.There was no blood loss and blood transfusion was not required.There was no patient symptoms or complications associated with this 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.

Event Description

According to the reporter, after angioplasy, when the tech removed the balloon/product through the sheath and the back end of the split apart from the catheter.It was stated that the balloon disconnected/detached from the rest of the device/catheter.It was also stated that the balloon luer connector was detached (luer adapter came apart from the catheter).The detachment was spontaneous.There was no leak.The insertion site was treated with betadine prior to product placement/procedure.Flushing was performed per ifu (instruction for use) and there were no issues.The balloon was properly used and ifu (instruction for use) was followed, the balloon was deflated when removed, an inflation device used (inflation device make: bard, inflation device model: presto, the reported product with an inflation device from a competitor¿s brand), the device did not pass through a previously deployed stent, no resistance was encountered when advancing the device, resistance was encountered during the 1st attempt of pulling the device from sheath, no excessive force was used (during delivery or during withdrawal), tego was not utilized, introducer sheath was used (7 french, terumo) and the catheter was not repaired.The procedure was completed.There was no intervention/treatment required as a result of the event.There was no blood loss and blood transfusion was not required.There were no patient symptoms or complications associated wit h this event.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, e1 (prefix), g3 correction: e3.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: 15379751
• MDR Text Key: 305812341
• Report Number: 3011144059-2022-00005
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10884521812321
• UDI-Public: 10884521812321
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2022

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: 01/30/2024
• Device Model Number: CH12-40-75US
• Device Catalogue Number: CH12-40-75US
• Device Lot Number: 22200124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 10/03/2022; 12/08/2022
• Supplement Dates FDA Received: 09/27/2022; 10/18/2022; 12/16/2022
• 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