MAUDE Adverse Event Report: COOK INC BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number HNR4.0-35-65-P-8S-VCF

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 04/08/2015

Event Type  Injury  

Event Description

An angiogram was being performed on a male pt.The user facility was inserting the catheter and they had taken the wire out of the angiogram.They put in a 0.035 inch guide wire.When they did this, the wire went through what looks like the black portion of the catheter.They were able to remove everything from the pt with a snare.The user facility opened a new catheter to complete procedure.Additional information received from the district manager: "the snare had to be used to removed the catheter tip that broke off the catheter.The wire went straight through the catheter curve and that is how they knew something was wrong." a section of the device did not remain inside the pt's body.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4745995
• MDR Text Key: 5884262
• Report Number: 1820334-2015-00276
• 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: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: HNR4.0-35-65-P-8S-VCF
• Device Lot Number: 4527400
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2015
• Device Age: 19 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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