MAUDE Adverse Event Report: COOK, INC. BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number HNR4.0-35-100-P-10S-PI

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/29/2015

Event Type  Injury  

Event Description

During the retrieval of the catheter of a cv port(details unknown), the catheter disconnected from the port and flowed into the site near the right atrium.Retrieval of it was performed on (b)(6) 2015.The retrieval was conducted by a snare(details unknown) inserted from left femoral vein.Before grasping the flowed catheter with the snare to move the catheter to the site easier to seize it, a wire guide(another manufacturer) was advanced into right atrium through a sheath(another manufacturer) and inserted from right femoral vein.The complaint cook beacon tip royal flush plus flush catheter was advanced over the wire guide.Afterwards, attempts to catch and shift the flowed catheter with its pigtail was performed.However, when the beacon tip royal flush plus flush catheter reached right atrium, it was noticed that the shape of the tip was cleary odd.Therefore, the physician re-advanced the wire guide into the catheter while checking the location under fluoroscope; which confirmed the protrusion of the wire guide from the base of the pigtail.Thus, withdrawal of the beacon tip royal flush plus flush catheter was conducted.However, as the tip was almost separated, it could not be placed into the sheath.Therefore, the tip was purposely separated by the snare advanced from left femoral vein, and retrieval of the beacon tip royal flush plus flush catheter and the deliberately separated tip was completed successfully.No adverse effects to the patient after the completed procedure/retrieval have been reported.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control (qc), functional testing and a visual inspection of the complaint device was conducted for the purpose of this investigation.Product was returned in an opened and used condition.A visual inspection noted a circumferential separation, approximately 1.2cm distal of the bond joint - the catheter break point is jagged and split.The separated tip displays a partial circumferential separation [most likely the first break as described by the facility] at 6mm proximal of the tip.At the point where separation occurred from the catheter, [the purposeful separation] there is a 4mm longitudinal split.Per quality control, 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, damage, excess material or debris present." as part of cook incorporated's quality system procedures, each complaint is investigated and as part of the investigation, risk is assessed, based on severity, detect-ability and occurrence.Based on this analysis, action taken may include the following: continued monitoring of similar events, corrective action or preventive action.The most likely severity ranges from low impact to minor harm, which is what occurred in this case.The appropriate personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH 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: 4947119
• MDR Text Key: 6636950
• Report Number: 1820334-2015-00442
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2015

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 Catalogue Number: HNR4.0-35-100-P-10S-PI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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