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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/24/2015

Event Type  Injury  

Event Description

During a tace(transcatheter arterial chemoembolization) procedure in the common hepatic artery on a (b)(6) male patient with hcc (hepatocellular carcinoma), the physician used the beacon tip torcon nb advantage angiographic catheter to try to get into the common hepatic artery (from celiac trunk to common hepatic artery).(there was a microcatheter inside this 4fr-rh catheter).After a while, the physician failed to get into the hepatic artery, so she pulled out the rh catheter.Around the aorta, she noticed that the tip of the catheter was broken and the radiopaque band part was separated.The physician used a snare to remove the radiopaque band.The radiopaque band separated in two pieces as it was being snared, with one piece separating under the skin.Both pieces were removed by the physician.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

Udi#:(b)(4).Patient code: additional surgical procedures is not labeled.Device code: material separation is not labeled.The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, device history record, instructions for use (ifu), quality control, trends and a visual inspection of the returned used product was conducted during the investigation.The visual examination revealed the device had separated approximately 4mm distal of the bond.The material looks to be intact with damage only concentrated in the bond.There is a slight jaggedness/tearing displayed on the break point; however, the separated segment of the tip was not returned.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 graft should be avoided whenever possible." / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." action has previously been taken in an effort to investigate the cause of this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

During a tace (transcatheter arterial chemoembolization) procedure in the common hepatic artery on a (b)(6) year old male patient with hcc (hepatocellular carcinoma), the physician used the beacon tip torcon nb advantage angiographic catheter to try to get into the common hepatic artery (from celiac trunk to common hepatic artery).(there was a microcatheter inside this 4fr-rh catheter).After a while, the physician failed to get into the hepatic artery, so she pulled out the rh catheter.Around the aorta, she noticed that the tip of the catheter was broken and the radiopaque band part was separated.The physician used a snare to remove the radiopaque band.The radiopaque band separated in two pieces as it was being snared, with one piece separating under the skin.Both pieces were removed by the physician.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4943364
• MDR Text Key: 6196072
• Report Number: 1820334-2015-00451
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

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: 06/01/2016
• Device Model Number: N/A
• Device Catalogue Number: HNBR4.1-NT-80-P-NS-RH
• Device Lot Number: 4317073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2015
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• 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: 66 YR