MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX OPEN-ENDED SINGLE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1716000

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records 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.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 that the patient has pain from the port to her heart.There has been issues with clotting and blood return.Medication has not controlled the pain.Three x-rays have showed the port to be okay.

Event Description

It was reported that the patient has pain from the port to her heart.There has been issues with clotting and blood return.Medication has not controlled the pain.Three x-rays have showed the port to be okay.

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged difficulty aspirating as no objective evidence has been provided to confirm any alleged deficiency with the port or catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include fibrin sheath formation and occlusion; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.A review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX OPEN-ENDED SINGLE
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7466467
• MDR Text Key: 106701004
• Report Number: 2020394-2018-00490
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026744
• UDI-Public: (01)00801741026744
• Combination Product (y/n): N
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1716000
• Device Catalogue Number: 1716000
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other