MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI POWERPORT ISP; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1806062
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical images or medical records 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 or Problem Description
It was reported that the patient complained of swelling and tenderness at the port site.Upon injection of contrast, a distal fibrin sheath around the tubing in the svs was reportedly present and pressure was required to get forward flow.Reportedly after a few seconds, contrast was seen around the port reservoir.The port was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: one clearvue mri isp port was returned for evaluation.During functional evaluation three small leaks were noted on the base of the port body.Therefore, the investigation is confirmed for the alleged subcutaneous leak.The definitive root cause could not be determined based upon the available information.It is unknown if 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.(expiration date: 12/2016), pma/510k device evaluated by mfr (results), (conclusion).
Event or Problem Description
It was reported that the patient complained of swelling and tenderness at the port site.Upon injection of contrast, a distal fibrin sheath around the tubing in the svs was reportedly present and pressure was required to get forward flow.Reportedly after a few seconds, contrast was seen around the port reservoir.The port was removed and replaced.There was no reported patient injury.

• Brand Name: MRI POWERPORT ISP
• 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: 7682350
• Report Number: 3006260740-2018-01708
• Device Sequence Number: 19178487
• Product Code: LJT
• UDI-Device Identifier: 00801741026966
• UDI-Public: (01)00801741026966
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1806062
• Device Catalogue Number: 1806062
• Device Lot Number: REZF2438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1