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

Catalog Number HNR4.0-35-70-ST-10S-PI

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 04/07/2015

Event Type  Injury  

Event Description

The complaint catheter was advanced through the right groin for a angiography of the aorta.When the physician was retrieving the catheter after the angiography, although no resistance was encountered during the retrieval, the tip separated and remained in the area around the right femoral artery.A wire guide was not used when retrieving the catheter.A snare was advanced from left femoral artery and the separated segment was retrieved out of the body successfully with it.There were no adverse effects to the patient.

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, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4730821
• MDR Text Key: 21463340
• Report Number: 1820334-2015-00254
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2015

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: HNR4.0-35-70-ST-10S-PI
• Device Lot Number: F4473214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2015
• Device Age: 19 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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