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

Model Number	CH10-40-75US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the nurse went to open the balloon and it was snapped in half.The balloon never touched the patient.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.The product was replaced with different lot.There was no patient involvement.
Event or Problem Description
According to the reporter, during procedure, the nurse went to open the balloon and it was snapped in half.The balloon never touched the patient.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Nothing else unusual observed on the device.No other defects/damages found on the product.There was no damage to the device's packaging and to the device's box.The product was replaced with different lot 2-3 days after the incident and this resolved the issue but they still have some of these lots numbers on their shelf.There was no reported patient outcome.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during procedure, the nurse went to open the balloon and it was snapped in half.The balloon never touched the patient.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Nothing else unusual observed on the device.No other defects/damages found on the product.There was no damage to the device's packaging and to the device's box.The product was replaced with different lot three days after the incident and this resolved the issue but they still have some of these lots numbers on their shelf.There were no confirmed issues observed with these remaining lot numbers on their shelf.There was no reported patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during procedure, the nurse went to open the balloon and it was snapped in half/broken in the packaging.The balloon never touched and was never in contact with the patient.No excessive force used.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Nothing else unusual observed on the device.No other defects/damages found on the product.There was no damage to the device's packaging and to the device's box.The product was replaced with different lot 3 days after the incident and this resolved the issue but they still have some of these lots numbers on their shelf.There were no confirmed issues observed with these remaining lots numbers on their shelf.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: removed a1, b5, g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during procedure, the nurse went to open the balloon and it was snapped in half/broken in the packaging.The balloon never touched and was never in contact with the patient.No excessive force used, the snapping in half of the balloon was spontaneous (unforced).The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Nothing else unusual observed on the device.No other defects/damages found on the product.There was no damage to the device's packaging and to the device's box.The product was replaced with different lot three days after the incident and this resolved the issue but they still have some of these lots numbers on their shelf.There were no confirmed issues observed with these remaining lots numbers on their shelf.There was no reported patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during procedure, the nurse went to open the balloon and it was snapped in half/broken in the packaging.The balloon never touched and was never in contact with the patient.No excessive force used, the snapping in half of the balloon was spontaneous (unforced).The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Nothing else unusual observed on the device.No other defects/damages found on the product.There was no damage to the device's packaging and to the device's box.The product was replaced with different lot 3 days after the incident and this resolved the issue but they still have some of these lots numbers on their shelf.There were no confirmed issues observed with these remaining lots numbers on their shelf.The procedure was completed.There was no reported patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one chameleon catheter.The catheter was broken into (b)(4) pieces at the distal end of the cannula near the balloon.A portion of the cannula where the break occurred appeared to be deformed.It was reported that there was detachment of the balloon.The reported issue was 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CHAMELEON
• Common Device Name: 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: 19264486
• Report Number: 3011144059-2024-00003
• Device Sequence Number: 2582019
• Product Code: KRA
• UDI-Device Identifier: 10884521812314
• UDI-Public: 10884521812314
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2025
• Device Model Number: CH10-40-75US
• Device Catalogue Number: CH10-40-75US
• Device Lot Number: 22301300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 05/16/2024; 06/12/2024; 07/10/2024; 07/15/2024; 08/20/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/05/2024; 07/02/2024; 07/15/2024; 08/06/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown