MAUDE Adverse Event Report: MEDTRONIC, INC SITESEER 6F DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 6A0019

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Event Description

The physician was attempting to use a siteseer diagnostic catheter during a radial diagnostic procedure.The catheter was removed from packaging, inspected and prepped per ifu with no issues noted.The catheter was flushed with saline and heparin.Then a non mdt 0,038" guidewire was inserted during prep.The wire was also green.The siteseer was advanced into the patient, and at the hub of the catheter green liquid was seen coming back through the inner lumen, followed by blood.This green color was captured on a white sterile tissue containing heparin.No patient injury reported.

Manufacturer Narrative

The complaint device was reported lost and was not received for evaluation.Received for analysis was a gauze wipe with green staining on it.Green residual (staining) is visible on the gauze.There is no measurable particulate or debris present under 50x magnification.It appears as fluid stain only.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SITESEER 6F DIAGNOSTIC CATHETER
• 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: 6180327
• MDR Text Key: 62531741
• Report Number: 1220452-2016-00079
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K932092
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6A0019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2017
• 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