MAUDE Adverse Event Report: COVIDIEN (IRVINE) REFLEX CATHETER; CATHETER, PERCUTANEOUS

Device Problem Flaked (1246)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis, as it was discarded at the site.Attempts to gather additional information have been made however, our attempts have been unsuccessful.The investigation is still underway.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that post the endovascular procedure, the patient was reported to have experienced an adverse event (unspecified).Per the treating physician, it is believed the lining from one of catheters used during the procedure showered in the brain.After the procedure, the follow up scans were reported to have been normal.Multiple catheters were used during the procedure.The treating physician did not state which catheter device may have caused this event.

• Brand Name: REFLEX CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7610102
• MDR Text Key: 111346075
• Report Number: 2029214-2018-00554
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Other