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

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

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Part of radiopaque broken off; remaining in the pt's body.The physician used a snare to take it out and took a new catheter to finish relevant procedure.The pt did not experience any adverse effects due to this observation.

Manufacturer Narrative

(b)(4).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 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4377173
• MDR Text Key: 5264935
• Report Number: 1820334-2014-00670
• 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: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• 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-RIM
• Device Lot Number: 4392237
• Other Device ID Number: (01)00827002135857(17) 160701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2014
• Device Age: 17 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: No
• 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