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

Catalog Number HNBR4.1-NT-80-P-NS-RL

Device Problem Component(s), broken (1103)

Patient Problem Foreign body, removal of (2365)

Event Date 01/13/2014

Event Type  Injury  

Event Description

During a computed tomography for g-i bleeding on a (b)(6) male patient, the physician tried to use rlg to ima, however, he found the tip had come off a little bit.He attempted to pull back, but it broke around cfa.The physician used a crs-100 to catch it out of the body.The patient did not require any additional procedures due to this occurence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Additional device info: catalog # - hnbr4.1-nt-80-p-ns-rlg.(b)(4).Event evaluation - still under investigation.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC.; bloomington IN
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3624824
• MDR Text Key: 4174106
• Report Number: 1820334-2014-00048
• 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
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2015
• Device Catalogue Number: HNBR4.1-NT-80-P-NS-RL
• Device Lot Number: 3734787
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2012
• 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: 55 YR
• Patient Weight: 86