MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM IMPLANTABLE PORT

Catalog Number UNK PORT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Occlusion (1984); Pneumothorax (2012); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article review: the journal article was a retrospective of 12 years from 2003 through 2015 to include a total of 527 port-a-cath¿s placed in adult patients.262 chest ports were placed in the operating room and 265 chest ports were performed in an outpatient clinic.Patient characteristics were similar; there is no significant difference in early versus late complications.Bard titanium implantable ports and districath ports were used for the study.Port-a-cath tip malposition was observed in seven cases which required repositioning under guided fluoroscopy.Pneumothorax occurred in three cases: one patient was treated conservatively, one patient required hospitalization with a chest tube insertion, and the third patient had a chest tube insertion an outpatient clinic.Later complications include venous thrombosis in one patient and treated with the low molecular weight heparin.Catheter occlusion occurred in four patients which required port-a-cath removal and replacement.Feo, c., ginesu, g., bellini, a., cherchi, g., scanu, a., cossu, m., fancellu, a., porcu, a.(2017).Cost and morbidity analysis of chest port insertion in adults: outpatient clinic versus operating room placement (2017).Annals of medicine and surgery, 21, 81-84.Http://dx/doi.Org/10.1016/j.Amsu.2017.07.057.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported in an article in annals of medicine and surgery titled 'cost and morbidity analysis of chest port insertion in adults: outpatient clinic versus operating room placement', that a 12 year retrospective for port-a-cath placements in 527 patients was performed.Reported complications included: port-a-cath tip malposition, pneumothorax which resulted in chest tube insertion, venous thrombosis, and catheter occlusion.

• Brand Name: TITANIUM IMPLANTABLE PORT
• Type of Device: TITANIUM IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7948646
• MDR Text Key: 123132132
• Report Number: 2020394-2018-01880
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• 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
• Treatment: HEPARIN
• Patient Outcome(s): Hospitalization; Life Threatening