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

Catalog Number HNR4.0-35-90-P-8S-VCF

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564)

Event Date 10/20/2014

Event Type  Injury  

Event Description

During a leg angio procedure, the vcf catheter was advanced over the terumo glide wire into the aorta for a flush angiogram.It was noted that the tip of the catheter was not totally connected to the catheter at this stage.The wire was introduced back into the catheter and the catheter removed, with the tip of the catheter separating inside the patient.The patient was taken to theatre as the tip was in the external iliac.The common femoral artery was operated on and a balloon thrombectomy was used to remove the tip.No information was provided regarding patient outcome.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: BEACON TIP ROYAL PLUS FLUSH CATHETER
• Type of Device: DQO 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: 4254635
• MDR Text Key: 5106842
• Report Number: 1820334-2014-00609
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/30/2014

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: HNR4.0-35-90-P-8S-VCF
• Device Lot Number: 4522706
• Other Device ID Number: (01)00827002129993(17)160901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2014
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/05/2014
• 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