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 No Consequences Or Impact To Patient (2199)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

The device was used during procedure of teavr with najuta 40mm and a zenith thoracic endovascular graft on (b)(6) patient with taa on (b)(6) 2014.Ax-ax bypass was performed.Another manufacturer's wire guide was going to be used for pull-through technique from the right brachial artery to the right femoral artery.There was no severe tortuosity or calcification from the axillary artery to brachiocephalic artery.After 6fr.Twin sheath was inserted from the right brachial artery over a wire guide, the complaint device, a beacon tip royal flush plus flush catheter, was advanced over the wire guide too.The wire guide was removed to be changed with radifocus.

Manufacturer Narrative

(b)(4).The event is currently under investigation.Since the physician encountered resistance during advancement of radifocus to the right fa, he removed the complaint device from the pt then found that the device tip was broken and missing.Another beacon tip royal flush plus flush catheter of the same lot was used instead.However, the same event, the same event, breakage and missing of the device tip, occurred again.Fortunately, separated segment of the device tips remained inside the sheath in both cases, which did not harm the pt.The sheath was changed with another one of the same specifications and catheter was changed with another manufacturer's.The procedure was completed with no problem.There have been no adverse effects to the pt reported.

• 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: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4321821
• MDR Text Key: 5249626
• Report Number: 1820334-2014-00603
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: HNR4.0-35-70-P-10S-PIG
• Device Lot Number: 4529854
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2014
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR