MAUDE Adverse Event Report: COOK, INC. BEACON TIP TORCON NB ADVANTAGE ANTIOGRAPHIC CATHETER

Catalog Number HNBR4.0-35-40-P-NS-KM

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 05/18/2015

Event Type  Injury  

Event Description

During a peripheral angiogram procedure, the catheter sheared off within the patient.A snare was used to remove the fragmented parts of the catheter.All parts were removed and there was no harm to the patient.No additional procedure was required as a result of this incident.No adverse effects to the patient were reported due to this occurrence.

Manufacturer Narrative

(b)(4).A review of the complaint history, instructions for use and quality control was conducted for the purpose of this investigation.The product was returned in an open and damaged condition.The tip of the catheter split lengthwise and separated approximately 7mm distal to the bond.Quality inspection final inspection for angiographic catheters states: "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 instructions for use 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.Measures have been taken in an effort to reduce the potential for future complaints of this nature.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANTIOGRAPHIC CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4845048
• MDR Text Key: 5912970
• Report Number: 1820334-2015-00350
• Device Sequence Number: 1
• Product Code: DQO
• 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,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: HNBR4.0-35-40-P-NS-KM
• Device Lot Number: 4490668
• Other Device ID Number: SEE F.10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2015
• Device Age: 20 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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