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

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

Patient Problem Fistula (1862)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

The catheter was not returned as it was discarded at the site.Based on the reported information, there was no allegation that a malfunction or deficiency of the device occurred during the procedure.There is no evidence suggesting that the device was defective, but rather a procedure related event.However, the exact cause remains unknown.Vessel damage is known inherent risk of endovascular procedure and are documented in the device's instruction for use.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the catheter caused an arteriovenous fistula (avf).However, the patient was reported to have been asymptomatic.The avf developed at the cavernous sinus.The patient¿s condition was just monitored and no additional medical treatment was provided.The avf was confirmed to have disappeared by mra on (b)(6) 2016.The patient was determined to have recovered on (b)(6) 2016.The physician determined the issue was caused by use of support catheter; the distal tip of the catheter damaged the vessel at petrous portion internal carotid artery through cavernous sinus during delivery.

• 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: 7237000
• MDR Text Key: 98862431
• Report Number: 2029214-2018-00078
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/02/2018

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: 01/23/2018
• Initial Date FDA Received: 02/02/2018
• 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
• Patient Age: 36 YR
• Patient Weight: 54