MAUDE Adverse Event Report: COOK, INC. BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number HNBR5.0-35-100-P-NS-SIM2

Device Problem Difficult to Advance (2920)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 08/15/2014

Event Type  Injury  

Event Description

The physician was attempting to get the wire thru the catheter; however, with much difficulty.After several attempts the physician was able to get the wire thru the catheter.The physician thinks maybe something was loose inside the catheter and broke off.The facility could not confirm the physicians' statement as there was not any extra material lying around.The pt did not require any add'l procedure due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Unable to confirm whether or not any item broke and/or remained in pt.Event is still under investigation.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden, dir. ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4089895
• MDR Text Key: 4743369
• Report Number: 1820334-2014-00433
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: HNBR5.0-35-100-P-NS-SIM2
• Device Lot Number: 4679051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2013
• 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