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

Catalog Number HNBR5.0-35-100-P-NS-SIM1

Device Problem Tip breakage (1638)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Foreign body, removal of (2365)

Event Date 06/03/2015

Event Type  Injury  

Event Description

The doctor reported that he was performing a routine cerebral angiography procedure on the (b)(4) male patient.The physician was using the angiographic catheter as per instructions for use (ifu) guidelines.As he was torqueing the catheter (with the guide wire insitu) the catheter tip broke off and traveled to the patient's iliac artery.The dr.Scrubbed in and managed to retrieve the broken tip from the patients vessels using another manufacturer's snare device.It was reported the retrieval process took approximately 2 hours.The patient was returned to the ward where he stayed overnight and returned to radiology the next day and the initial procedure was completed without any further incident.No additional information was provided regarding patient outcome.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

A review of the complaint history, instructions for use (ifu), quality control (qc) and a visual inspection of the returned opened and used device was conducted during the course of investigation.The patient event information stated that the doctor reported that he was performing a routine angiography on the (b)(6) male patient.He was using the sim1 catheter as per ifu and as he was torquing the catheter (with the guide wire insitu the catheter tip broke off and traveled to the patients' iliac artery.The doctor scrubbed in and they managed to retrieve the broken off tip from the patients vessels using another manufacturers snare device.Per quality control specification, it is stated "verify surface of catheter is free of damage and excess bumps or roughness.Wire braided catheter surface must also be free of exposed wires " in addition, it states: "verify distal tip/endhole is rounded smooth, not thin, slanted, or out of round.No splits, nicks, damage, excess maternal or debris present." this product is shipped with an instructions for use (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." the appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera), preventative measures have already been initiated to investigate this failure mode.

• 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: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4898383
• MDR Text Key: 6072016
• Report Number: 1820334-2015-00386
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002084711
• UDI-Public: (01)00827002084711(17)151001(10)3746237
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: HNBR5.0-35-100-P-NS-SIM1
• Device Lot Number: 3746237
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2015
• Device Age: 20 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR