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

Catalog Number UNK-CV-DAN-DXT

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

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Embolism (1829); Unspecified Infection (1930); Muscle Spasm(s) (1966); Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Transient Ischemic Attack (2109); Reaction (2414); Vascular Dissection (3160)

Event Type  Injury  

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.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
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9744282
• MDR Text Key: 188486460
• Report Number: 1220452-2020-00024
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-DAN-DXT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• 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): Other