MAUDE Adverse Event Report: MEDTRONIC, INC ZUMA Z2 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number Z26EBU375

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

Patient Problem Insufficient Information (4580)

Event Date 04/05/2023

Event Type  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

An attempt was made to use one 6f zuma guide catheter in the proximal left main (lm) coronary artery.The device was inspected with no issues.The device was prepped per ifu with no issues.It was reported that the tip appeared defective, and got stuck in the femoral artery in the leg.It was detailed that the catheter was lightly twisted to engage in the left coronary, without feeling much resistance at first.It looked like the tip was defective and an attempt was made to pull out the device.However, when it was attempted to remove the device the tip got stuck in the femoral artery.A femoral cut-down surgical procedure had to be performed to remove the detached tip.The patient had catheterization procedure two days later with a radial approach and is reported to be doing well.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: vessel tortuosity was unclear.The event occurred during initial attempts to engage the device, and it is unknown if the device was in the lesion.There was a slight resistance when advancing the device, but no excessive force was used.The device got kinked once in the patient when the device was turned to engage.The distal tip did not detach.Patient sex, weight.Image review: one procedural image still photo was provided from the account.The image appears to show the guide catheter (gc) in the femoral artery with the procedural guidewire (gw) evident in the gc.There appears to be damage to the gc on the distal end and the gw does not appear possible to deliver the gw in a straight line through the gc this suggests that the gc is deformed or kinked, thus preventing direct passage of the gw.There is no evidence of a tip detachment on the procedural images.Image review: the image provided does not capture the length of the guide catheter.It captures only the proximal section of the device, and it appears to show where the guide catheter shaft was cut.There are kinks on the shaft of the device, proximal and distal of the cut site.Proximal of the cut site, the shaft appears twisted with tortional kinks however it is not possible to determine if any braiding is exposed.An image of the distal section of the device was not provided so it is not possible to determine if the tip was defective.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

Image review: one device photo was provided from the account.The photo shows a kinked damage and detached guide catheter.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: ZUMA Z2 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16774628
• MDR Text Key: 313628847
• Report Number: 1220452-2023-00047
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00613994813022
• UDI-Public: 00613994813022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981198
• 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
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z26EBU375
• Device Catalogue Number: Z26EBU375
• Device Lot Number: 0011541444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Date Device Manufactured: 12/07/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 93 KG