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

Catalog Number HNR4.0-35-70-P-10S-PIG

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 03/13/2015

Event Type  Injury  

Event Description

After inserting an ivc filter in a patient with peripheral artery disease, the distal tip separated inside the patient during a contrast injection.The distal tip had to be retrieved using a snare.No harm was caused to the patient as a result of this incident.No part of the device remained inside the patient as it was retrieved using a snare.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

• 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 ; 8123362235
• MDR Report Key: 4707594
• MDR Text Key: 16178569
• Report Number: 1820334-2015-00193
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: HNR4.0-35-70-P-10S-PIG
• Device Lot Number: 4539617
• Other Device ID Number: (01)00827002094062(17)161001(1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2015
• Device Age: 17 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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