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

Catalog Number HN4.0-35-100-P-10S-PIC

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 10/22/2014

Event Type  Injury  

Event Description

The complaint device was used to tevar on (b)(4) 2014.When the physician was removing the catheter after angiography, the tip of the catheter separated.The separated part of catheter could be seen under radiographic guidance.However, since the separated part of catheter remained on the wire guide, it could be retrieved from the pt with snare.No additional information has been provided by the reporter.

Manufacturer Narrative

(b)(4).

• 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: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4257501
• MDR Text Key: 5013183
• Report Number: 1820334-2014-00589
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• 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: HN4.0-35-100-P-10S-PIC
• Device Lot Number: F4499348
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2014
• Device Age: 13 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2014
• 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