MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CATHETER CENTRAL VENOUS 4.2FR 90CM 1 LUMEN 2 CONNECTOR BROVIAC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600524

Device Problems Material Erosion (1214); Fluid/Blood Leak (1250)

Patient Problems Arrhythmia (1721); Cardiomyopathy (1764); Pleural Effusion (2010); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/20/2022

Event Type  No Answer Provided  

Event Description

Situation: rrt (rapid response team) called for a patient with respiratory distress and decreased lvad (left ventricular assist device) fill/empty.Patient emergently transferred and chest xray revealed a new large pleural effusion.Upon placement of chest tube tpn and lipid appearing fluid "gushed" out of the chest tube.It appears her ra (right atrium) broviac had eroded or been displaced.Background: patient is adolescent with charge syndrome and tof/pa (tetralogy of fallot with pulmonary atresia) had an intracardiac repair with lpa (left pulmonary artery) patch augmentation, rv-pa (right ventricle ¿ pulmonary artery) conduit placement, asd (atrial septal defect) closure and pda (patent ductus arteriosus) ligation.Post-op tee (transesophageal echocardiogram) showed good biventricular function, well-functioning valves with no residual lesions.Her post-op course was complicated by (b)(6) mediastinitis, eat, moderate mr (mitral regurgitation) and worsening ventricular function.She continued with arrhythmias, progressive lv dysfunction, moderate-severe mr, moderate tr and lv noncompaction/dilated cardiomyopathy so a decision was made to go to the or for a berlin lvad.In operating room berlin and broviac was placed with the tip of broviac ending in the ra.Prior to chest tube placement and intubation patient was given sedation/paralytic in broviac with no response despite multiple doses.With this new finding provider aware broviac may not be in the right place.Event was investigated for potential broviac leak.Unable to determine causation between potential deviation from standards of care and additional harm to the patient.Opportunity identified to evaluate and clarify standards of care around routine assessments of patency and position of intracardiac lines.Broviac product info from supply chain usage report: vendor name: bard peripheral vascular inc.Item description: catheter central venous 4.2fr 90cm 1 lumen surecuff stylet peel apart injection cap 2 connector broviac pediatric latex free.Item id: (b)(4).Manufacturing id: (b)(4).Manufacturing item id: (b)(4).

• Brand Name: CATHETER CENTRAL VENOUS 4.2FR 90CM 1 LUMEN 2 CONNECTOR BROVIAC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 14282262
• MDR Text Key: 290696976
• Report Number: 14282262
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 0600524
• Device Catalogue Number: 0600524
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Date Report to Manufacturer: 05/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA
• Patient Sex: Female