MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1806060J

Device Problem Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); Swelling (2091); No Consequences Or Impact To Patient (2199); Reaction (2414)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 port was accessed and abraxane (paclitaxel) was administered.During infusion the patient experienced redness from the neck through the upper clavicle and edema on the legs and right arm.The patient¿s symptoms cleared up after several days.The physician discontinued using the port and administered the drugs via peripheral vein.Similar symptoms were observed.The port was removed.The physician stated that a leak in the catheter was not found.The status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one powerport isp mri with chronoflex catheter was returned for evaluation.The device was returned with the catheter attached to the port stem under the catheter lock.Wear was noted between the 13cm and 18cm depth markers.No other anomalies were noted.The sample was patent to both infusion and aspiration with no leaks noted.Based on this finding, the investigation is unconfirmed for the reported potential leak.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that the port was accessed and abraxane (paclitaxel) was administered.During infusion the patient experienced redness from the neck through the upper clavicle and edema on the legs and right arm.The patient¿s symptoms cleared up after several days.The physician discontinued using the port and administered the drugs via peripheral vein.Similar symptoms were observed.The port was removed.The physician stated that a leak in the catheter was not found.The status of the patient is unknown.

Event Description

It was reported that the patient had the port implanted via the right internal jugular vien, and the port was accessed and abraxane (paclitaxel) was administered.During infusion the patient experienced redness from the neck through the upper clavicle and edema on the legs and right arm.The patient¿s symptoms cleared up after several days.The physician discontinued using the port and administered the drugs via peripheral vein.Similar symptoms were observed.The port was removed.The physician stated that a leak in the catheter was not found.The status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one powerport isp mri with chronoflex catheter was returned for evaluation.The device was returned with the catheter attached to the port stem under the catheter lock.Wear was noted between the 13cm and 18cm depth markers.No other anomalies were noted.The sample was patent to both infusion and aspiration with no leaks noted.Based on this finding, the investigation is unconfirmed for the reported potential leak.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provided by bd 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 bd.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7906031
• MDR Text Key: 121765957
• Report Number: 3006260740-2018-02574
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111624
• UDI-Public: (01)00801741111624
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1806060J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 48