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 No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure, the catheter tip fractured during manipulation and the tip fractured.The tip was retrieved with a snare.No impact to the patient has been reported.

Manufacturer Narrative

(b)(4).Investigation- a review of the complaint history, device history record, instructions for use (ifu), quality control (qc), specifications, and documentation was conducted for the purpose of this investigation.The product was not returned to assist with the investigation.A recall expansion was initiated for beacon tip torcon nb advantage angiographic catheter on (b)(6) 2015.However, this product is not within the scope of the recall.Prior to shipment the manufacturer, confirms the tip material meets the requirements for tensile strength and elongated.Quality control performs the following in-process and requires the following inspections: ¿perform a pull test using the instron tensile tester on each order received.¿ / "verify surface of catheter is free of damage and excess bumps or roughness.Wire braided catheter surface must also be free of exposed wires¿ / "verify distal tip/endhole is rounded smooth, not thin, slanted or out of round.No splits, nicks, damage, excess material or debris present." this product is shipped with an ifu which states under precautions: "due to thin wall 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." measures have previously been taken to address this issue.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.

Event Description

During the procedure, the catheter tip fractured during manipulation and the tip fractured.The tip was retrieved with a snare.No impact to the patient has been reported.

• 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: 5334320
• MDR Text Key: 34664629
• Report Number: 1820334-2015-00873
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

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 Model Number: N/A
• Device Catalogue Number: HNBR5.0-38-100-P-NS-SIM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/20/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR