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

Model Number CH12-40-75US

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: ch10-40-75us, chameleon ch10-40-75us 10mmx40mm x 75cm (lot#: 22202176) 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, the first balloon (size 12millimeterx40mmx75centimeter) was deflated and became hung up in an introducer sheath and actually sheared off (uncertain if completely detached) about 1.5 inches above the sheath.They had to use another introducer sheath to fish it out.The other balloon (size 10x4) was working fine and then taken out of the patient during a declot case.When the balloon was reinserted, the balloon was not able to open once inside the patient.They removed the balloon and it appeared that part of the balloon was getting hung up on itself on the injection port.The catheter was not repaired and there was no leak.There was no luer connector issue.There was nothing unusual observed on the device prior to use.Introducer sheath (french 7), contrast, saline and 0.35 guidewire were utilized with the device.Flushing was done as per ifu (instruction for use) and had a normal/good outcome.There was no reported cleaning agent used on the device.The balloon was inflated using a syringe and standard inflation fluid was used.A maximum inflation pressure was applied when it was determined that there was inflation difficulties.The device passed through a previously deployed stent.It was also mentioned that the detached portion of the device did not remain in the patient.The product was replaced to resolve the issue and procedure was completed.Intervention was required as a result of the event.There was no reported blood loss and blood transfusion was not required.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, the first balloon (size 12millimeterx40mmx75centimeter) was deflated and became hung up in an introducer sheath and actually sheared off (completely detached) about 1.5 inches above the sheath.They had to use another introducer sheath to fish it out.The other balloon (size 10mmx40mmx75cm) was working fine and then taken out of the patient during a declot case.When the balloon was reinserted, the balloon was not able to open once inside the patient.They removed the balloon and it appeared that part of the balloon was getting hung up on itself on the injection port.The catheter was not repaired and there was no leak.There was no luer connector issue.There was nothing unusual observed on the device prior to use.Introducer sheath (french 7), contrast, saline and 0.35 guidewire were utilized with the device.Flushing was done as per ifu (instruction for use) and had a normal/good outcome.There was no reported cleaning agent used on the device.The balloon was inflated using a syringe and standard inflation fluid was used.A maximum inflation pressure was applied when it was determined that there was inflation difficulties.The device passed through a previously deployed stent.It was also mentioned that the detached portion of the device did not remain in the patient.It was mentioned that the physician believed that both balloons were damaged due to the providers not allowing the balloons to properly deflate before moving them out of the patient.They did not believe the issue to be of the balloons but of the clinical approach.The product was replaced to resolve the issue or as intervention due to the event and procedure was completed.There was no reported blood loss and blood transfusion was not required.There was no reported patient injury.

• 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: 17240871
• MDR Text Key: 318396691
• Report Number: 3011144059-2023-00005
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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 Model Number: CH12-40-75US
• Device Catalogue Number: CH12-40-75US
• Device Lot Number: 22202213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/19/2023
• 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 Sex: Female