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

Model Number N/A

Device Problems Material Separation (1562); Tip breakage (1638)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Type  Injury  

Event Description

Information was provided that during a procedure, the user was inserting the catheter (they had removed the wire out of the angiogram).They inserted a.035 guide wire; however, the wire went through the black portion of the catheter.The user was able to remove everything from the patient with a snare.A new catheter was opened to complete the procedure.Additional information was provided that stated: "the snare had to be used to remove the catheter tip that broke off the catheter.The wire went straight through the catheter curve and that's how they knew something was wrong." the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).A review of complaint history, instructions for use (ifu), quality control and a visual inspection was conducted during the investigation.A visual inspection of the returned opened and used device noted that the distal tip had separated from the catheter shaft.The end of the distal tip was split in two from where the wire went through the tip.This likely is splitting along the stripe of tungsten filled material that renders the tip radiopaque.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

Information was provided that during a procedure, the user was inserting the catheter (they had removed the wire out of the angiogram).They inserted a.035 guide wire; however, the wire went through the black portion of the catheter.The user was able to remove everything from the patient with a snare.A new catheter was opened to complete the procedure.Additional information was provided that stated: "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's how they knew something was wrong." the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4811812
• MDR Text Key: 5927739
• Report Number: 1820334-2015-00328
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HNR4.0-35-65-P-8S-VCF
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• 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