MAUDE Adverse Event Report: COOK, INC. BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number HNBR5.0-38-80-P-NS-RH

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 05/24/2014

Event Type  Injury  

Event Description

(b)(6) male patient with liver cancer was conduced transcatheter arterial chemoembolization procedure for the third time on (b)(6) 2014.Catheter was checked by appearance inspection in visual.It was normal.The tip of catheter was broken while inducted into the bifurcation of total arterial skeletons, and was flushed by the blood to the distal end of sheath and became stuck.The rest of the catheter was removed from the patient.Patient was conducted additional procedure on (b)(6) 2014 to remove the tip of catheter which stuck with a grabber.Procedure was completed and the tip was removed successfully.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Product was returned in an opened and used condition.A visual inspection noted that the distal tip had separated from the catheter shaft.The tip appeared to be stretched and the edges were uneven.A review of complaint history, review of ifu, review of quality control procedures and specifications and visual inspection was performed during our investigation process.Per quality control specification, the integrity of the catheter is verified, which also includes confirming there are no splits, nicks, damage, excess material or debris present.This product is shipped with an ifu which states under precautions: "due to thinwall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular grafts should be avoided whenever possible." "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." the patient event information stated that "the tip of catheter was broken while inducted into the bifurcation of total arterial skeletons, and was flushed by the blood to the distal end of sheath, and became stuck." based on the visual inspection of the returned device it appears the device was exposed to forces beyond its design.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per quality engineering risk assessment, no further risk reduction is required.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC 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: 3902229
• MDR Text Key: 16856317
• Report Number: 1820334-2014-00256
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/26/2014

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: 02/28/2016
• Device Catalogue Number: HNBR5.0-38-80-P-NS-RH
• Device Lot Number: 3989259
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2014
• Device Age: 15 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/26/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• 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
• Patient Age: 69 YR