MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY

Model Number U5ULTRA40SH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Injury (2348)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A dxterity diagnosis catheter was used during a procedure to treat a non tortuosity, none calcified lesion in the mid artery.There was no damage noted to the packaging.The device was removed from the packaging per ifu with no issues.The device was prepped per ifu with no issues.Resistance was not encountered and excessive force was not used.It was reported that a damping effect was observed after the contrast injection despite been in the aorta.The patient is alive with no injury.

Manufacturer Narrative

Additional information: it was stated that the 5 french dxterity catheter was parked at the ascending aorta and was not touching the wall.It was also stated that this is a normal diagnostic catheter used for this procedure.Four still images of arterial pressure waveform during coronary angiography and a procedural video were provided for analysis.The first two images provided show a significant decrease in aortic pressure with complete disappearance of the systolic and diastolic waveforms.Abnormal pressure wave can be confirmed.¿damping effect¿ can be confirmed from the image provided.The third image shows a decrease in aortic pressure but with systolic and diastolic characters in the waveforms which can suggest a mechanical obstruction and more likely certain vessel stenosis.The fourth image shows what appears to be re-establishment of aortic pressure.As it is unknown during what part of the procedure these images were taken and patient condition, it is difficult to state whether this systolic deflation is a finding or just normal observation.The video provided does not show a difference in the aortic pressure.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

Additional information: it was stated that the catheter was flushed with heparinized saline as part of the preparation before use.The catheter was noted to 'touch' the aorta, especially the left cusp.It was indicated that this could cause transient dampening if the catheter was temporarily positioned against the aorta.It was noted that this was a rare occurrence and the pressure would recover very quickly here.It was stated that it was highly unlikely that the pressure dampening had anything to do specifically with the dexterity catheter design.It was also stated that this complaint was not received before in the past with the millions of catheters sold.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: DXTERITY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 10256712
• MDR Text Key: 198295709
• Report Number: 1220452-2020-00057
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00763000016753
• UDI-Public: 00763000016753
• Combination Product (y/n): N
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: U5ULTRA40SH
• Device Lot Number: 60175311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1