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

Model Number CH12-40-75US

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, the balloon did not pass through a previously deployed stent; it was utilized with a 035 guide wire (bard), and resistance encountered when advancing it during first attempt.The balloon was inflated with syringe, no inflation fluid was used and it was deflated normally.After the anastomosis was cleared in the central artery, during removal/withdrawal of balloon/wire from the patient, excessive/additional force was used as there was some scare tissue in surrounding entrance site and the catheter broke/snapped at the side hole (exit port).This was a sheath less procedure.The doctor had to cut down and use snare to remove the balloon.No additional anesthesia required to perform the cutdown.Additional surgical time was needed.A diagnostic testing (fluoroscopy) was done as a part of procedure to verify if there were no parts retained on the patient¿s body.All pieces were accounted for and removed on the same day of the event.Nothing unusual observed on the device prior to use.The device was flushed with no issues identified.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.The insertion site was not treated with prior to product placement.Saline flush was the cleaning agent used on the device.There was no blood loss.Blood transfusion was not required.No additional medical treatments or medications.No hospital admission or prolonged hospitalization.The patient did not experience any symptoms and was in good condition.

Manufacturer Narrative

Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the catheter was bent in numerous places and the distal end was disengaged and not received.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 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

Correction: h6 (fdd) 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: 12546603
• MDR Text Key: 273777970
• Report Number: 3011144059-2021-00002
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 07290016745085
• UDI-Public: 07290016745085
• 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,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: CH12-40-75US
• Device Catalogue Number: CH12-40-75US
• Device Lot Number: 22100320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 86 KG