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

Model Number 103-0608

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

The device lot number was not reported.The device has not been returned for analysis; therefore the complaint could not be determined.Same event as reported in mdr mfr: 2029214-2016-00018.

Event Description

Medtronic received information that the physician found the mirage guidewire was coming out the side of the marathon catheter during an interventional surgery.It was reported that there was no kink or damage on the catheter nor the guidewire during preparation.The physician flushed the guidewire and loaded it on the catheter.While advancing the guidewire, the physician noticed that the guidewire was coming out from the side of the catheter.The physician replaced the catheter with a new one and the procedure was completed.The patient is doing well with no adverse events reported.

Manufacturer Narrative

The catheter and guidewire were returned for analysis.The stylet was found protruding from the catheter hub.No damages were observed on the catheter body.The stylet was removed from within the catheter without issue.No damages were found with the stylet.The catheter was flushed and found patent.The catheter did not have leaks, ruptures, or punctures.The guidewire was examined and the outer coils were found stretched, with the core wire intact.However, there was damaged and missing coating from the proximal segment.The guidewire tip was found bent at the distal segment.Due to the damaged condition of the guidewire, it could not be used for further testing.An in-house guidewire was able to be navigated through the catheter lumen without issue.No other anomalies were observed.Based on the reported information and the device analysis, the customer¿s report of ¿guidewire puncture¿ could not be confirmed.No damages or issues were found with the returned catheter.The catheter performed as intended with an in-house guidewire.However, the returned guidewire was found to be damaged.The cause for the damage to the guidewire and the reported experience could not be determined.Mdr related to this event: 2029214-2016-00018 2029214-2016-00019.

• Brand Name: MIRAGE GUIDEWIRE
• 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: 5357106
• MDR Text Key: 35557373
• Report Number: 2029214-2016-00019
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002212
• 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: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 103-0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 00050 YR
• Patient Weight: 55