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

Catalog Number HNR4.0-35-100-P-10S-PIG

Device Problem Tip breakage (1638)

Patient Problem Foreign body, removal of (2365)

Event Date 06/13/2014

Event Type  Injury  

Event Description

A female patient underwent a post cava procedure on (b)(6), 2014.The tip of the pig catheter was broken inside the patient while the physician withdrew the catheter from the patient.The broken tips were removed from the patient by wire guide afterward.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information provided (b)(6) 2014: pigtail tip was broken as one piece.Physician folded the tip of wire guide to a "loop" and captured the fragment.Pigtail tip fragment divided into two pieces after removed from the patient.The physician want to know why it tore apart, and touched the fragments, then the pigtail tip divided into three pieces.Information received (b)(6) 2014 regarding storage: device was stored at dry warehouse.Not exposed to uv lighting.

Manufacturer Narrative

(b)(4).Event evaluation: still 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
• Manufacturer (Section G): COOK, INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; p.o. box 489; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 3918860
• MDR Text Key: 16781941
• Report Number: 1820334-2014-00286
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/13/2014

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: 07/31/2014
• Device Catalogue Number: HNR4.0-35-100-P-10S-PIG
• Device Lot Number: F2661458X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2014
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2011
• 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