MAUDE Adverse Event Report: KENDALL USA SAN JOSE PLANT CHAMELEON; CATHETER, CONTINUOUS FLUSH

Model Number CH08-40-75US

Device Problems Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

According to the reporter, during treatment, the device's third port would not work.There was nothing unusual was observed on the device prior to use and flushing was performed per the ifu (instruction for use), and no issue was identified.There was no damage to the device's external packaging and box.The device was not repaired, there was no leak, tego was not utilized and there was no luer adapter issue.It was also stated that sheath and inflation device was being utilized with the device.Introducer sheath was used, the balloon was inflated and deflated.The device's tip had broke off from the shaft upon exit.The device was not successfully used.The balloon and catheter were removed to resolve the issue.The treatment was proceeded and completed.There was no medical intervention done to the patient and there was no patient symptoms or complications associated with this event.There was no 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.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

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the device was found to have been improperly assembled.A syringe was connected to the third luer port, but no water was able to be flushed through the port.Upon microscopic inspection of the port, it was noted that adhesive had dried in the port causing a blockage.It was reported that there was an exit port issue.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.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): KENDALL USA SAN JOSE PLANT; 5799 fontanoso way; san jose CA 95138
• Manufacturer (Section G): KENDALL USA SAN JOSE PLANT; 5799 fontanoso way; san jose CA 95138
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17014277
• MDR Text Key: 316336895
• Report Number: 3011144059-2023-00002
• Device Sequence Number: 1
• Product Code: KRA
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: CH08-40-75US
• Device Catalogue Number: CH08-40-75US
• Device Lot Number: 22000880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• 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