MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM POWERPORT ISP W/SP, 8 FR GROSHONG, INTER. KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1708560
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Swelling (2091); Thrombus (2101)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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.Medical device - expiration date: 11/2021.
Event or Problem Description
It was reported that approximately one month after the placement of the port device, it was allegedly unable to be aspirated.Reportedly, the health care provider was able to aspirate successfully after the administration of tissue plasminogen activator (tpa).It was further reported that the patient experienced an alleged swelling of the left arm.Reportedly, on dye study found that the tip of the port catheter was slightly retracted near the junction of the brachiocephalic veins without extravasation.It was further reported that an alleged thrombus was identified in the superior vena cava, left brachiocephalic vein, subclavian vein and proximal aspect of the cephalic vein.Reportedly, an additional intervention was required for thrombus formation and prevention, however, the patient was reportedly stable.

• Brand Name: TITANIUM POWERPORT ISP W/SP, 8 FR GROSHONG, INTER. KIT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8781678
• Report Number: 3006260740-2019-01916
• Device Sequence Number: 2639187
• Product Code: LJT
• UDI-Device Identifier: 00801741026706
• UDI-Public: (01)00801741026706
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1708560
• Device Catalogue Number: 1708560
• Device Lot Number: RECV1304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention