MAUDE Adverse Event Report: DXTERITY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number DXT5PIGSTA

Device Problem Use of Device Problem (1670)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A dexterity coronary diagnostic catheter was used to treat a lesion in the rca.The device was prepped with no issues noted.It was reported that the device was expired when used in the patient.No patient injury was reported.

Manufacturer Narrative

The device was inspected before use, after being removed from the box.The product is on consignment at the account, with a signed consignment agreement in place.Medtronic are responsible for controlling short dated/expired products at this account.This device was missing from the stock review for a long time before being used.Additional checks have been carried out in the store room to ensure that short dated or expired products are not available for use in the account.The patient is alive with no injury.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

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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12335394
• MDR Text Key: 267042358
• Report Number: 1220452-2021-00038
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00643169689558
• UDI-Public: 00643169689558
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: DXT5PIGSTA
• Device Catalogue Number: DXT5PIGSTA
• Device Lot Number: 60185169
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Date Device Manufactured: 05/14/2019
• 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