MAUDE Adverse Event Report: COOK INC BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number NR5.0-35-70-P-10S-PIG-CSC-20

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 11/21/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient had an endovascular repair of aaa with exclusion of the aneurysm.Another manufacturer's stent graft was used.During this procedure, the centimeter sizing catheter was used.On (b)(6) 2014, the patient underwent a femoral endarterectomy and patch angioplasty.The surgeon found what he thought was a segment of a catheter from a previous vascular intervention and removed it.It was sent to pathology and the user facility has studied it.From what the user facility understands, it is the "marker pigtail cath." the case was discussed on (b)(6) 2014 the user thinks that the item somehow "got sucked into the patient" at the time of the aaa repair in september, and was detected until the november procedure.The device portion was removed from the patient.

Manufacturer Narrative

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

• Brand Name: BEACON TIP AUROUS CENTIMETER VESSEL SIZING 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: 4377110
• MDR Text Key: 5239424
• Report Number: 1820334-2015-00009
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2017
• Device Catalogue Number: NR5.0-35-70-P-10S-PIG-CSC-20
• Device Lot Number: 5184583
• Other Device ID Number: (01)00827002312159(17)170815(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR