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

Catalog Number HNBR4.1-NT-80-P-NS-RI

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 04/14/2015

Event Type  Injury  

Event Description

Treatment of an embolism was being performed on a (b)(6) male with a pre-existing condition of right inferior epigastric artery bleeding.The physician used another manufacturer's 0.035 inch wire guide with the cook catheter to access the left common iliac artery.When the physician pulled the wire back to show the rim curve to crossover the bifurcation of common iliac artery, he saw the curve of the catheter was very strange.The physician pulled back the catheter around the site of the common femoral artery and stopped because he was afraid that the catheter would be totally broken.The physician used a snare to get the broken catheter out of patient's body successfully.According to the initial reporter, the patient did not experience any adverse effects after this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4730803
• MDR Text Key: 5735484
• Report Number: 1820334-2015-00262
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: HNBR4.1-NT-80-P-NS-RI
• Device Lot Number: 4392237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2015
• Device Age: 21 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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): Required Intervention
• Patient Age: 78 YR