MAUDE Adverse Event Report: COVIDIEN NITREX; WIRE, GUIDE, CATHETER

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

Patient Problems Hematoma (1884); Perforation (2001); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Survey results from an interventional radiologist in practice 22 years.Physician has been using medtronic¿s nitrex guidewires since 2017, using a total of 240 in the last year.100 were 0.36 mm (0.014 in) and / or 0.46 mm (0.018 in) diameter guidewires used during peripheral vasculature procedures.140 were 0.64 mm (0.025 in) and / or 0.89 mm (0.035 in) diameter nitrex guidewires were used in peripheral vasculature procedures.While using the 0.36 mm (0.014 in), the 0.46 mm (0.018 in), 0.64 mm (0.025 in) and / or 0.89 mm (0.035 in) diameter nitrex guidewires during peripheral vasculature procedures: irritation to vessel causing vessel spasm (2 patients), this was reversible after removal.Vessel perforation occurred when probing a calcified closure.Muscle hematoma without permanent damage (1 patient).These events were deemed to be not related to the device at all.

• Brand Name: NITREX
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8632006
• MDR Text Key: 145777054
• Report Number: 2183870-2019-00297
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040345
• 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
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2019
• 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