MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY TRA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number UNK-CV-DAN-DXT

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A post market clinical follow-up (pmcf) survey was conducted on behalf of medtronic to seek out potential new risks and assess performance of the dxterity diagnostic catheter.Survey results were obtained from an cardiovascular surgeon in practice 20 years.In the past 12 months the physician performed 180 procedures using the dxterity diagnostic catheter.30 procedures using the 5 fr x 100cm, 120 procedures using the intermediate sizes, and 30 procedures using the 6f x 125cm.The following complications adverse events/effects were reported when using the dxterity diagnostic catheter product over the last 12 months.2 dissection events occurred which were related to a pre-existing condition or comorbidity.4 thrombus formation events occurred which were related to a pre-existing condition or comorbidity.3 embolization events occurred which was related to a pre-existing condition or comorbidity.6 cardiac arrhythmia events occurred which were related to a pre-existing condition or comorbidity.2 myocardial infarction events occurred which were related to a pre-existing condition or comorbidity.4 stroke and transient ischemic attack events occurred which were related to a pre-existing condition or comorbidity.5 infection events occurred which were related to a pre-existing condition or comorbidity.10 allergic reaction events occurred which were related to a pre-existing condition or comorbidity.8 vasospasm events occurred which were related to a pre-existing condition or comorbidity.4 devices were damaged in the package before use.The events were directly related to the dxterity diagnostic catheter.The events were reported to be due to transport or storage issues.5 devices were damaged when removed from the package.The events were directly related to the dxterity diagnostic catheter.The events were reported to be due to transport or storage issues.3 devices had a defective tip.2 events were related to the procedure but not directly to the dxterity diagnostic catheter.One event was directly related to the dxterity diagnostic catheter.The events were alleged to be due to a defect during manufacturing.For 3 devices, the tip broke off/was damaged.2 events were related to the procedure but not directly to the dxterity diagnostic catheter.One event was directly related to the dxterity diagnostic catheter.The events were alleged to be due to a defect during manufacturing.

Manufacturer Narrative

The damage when removed from package events had no clinical/patient impact.The defective tip events had no clinical/patient impact.The tip broke off/was damaged events had no clinical/patient impact.None of the events had an impact on the procedure.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 TRA
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9784531
• MDR Text Key: 182922375
• Report Number: 1220452-2020-00032
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-DAN-DXT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1