MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN VENOUS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1718500
Medical Device Problem Codes	Material Frayed (1262); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return 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.Mw5079058; device not returned at this time.
Event or Problem Description
It was reported that the port and stylet were implanted in the patient, as the physician was unaware the catheter had a stylet.One year later a ct revealed that the stylet had broke and migrated the renal vein.The stylet was removed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information was provided by the complainant on 10/17/2018, associated fields were updated.No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Mw5079058.
Event or Problem Description
It was reported that the port and stylet were implanted in the patient, as the physician was unaware the catheter had a stylet.One year later a ct revealed that the stylet had broken and migrated the renal vein.The stylet was removed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and 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 reported to date for this lot number and failure mode.Investigation summary: one stylet segment from a pport ti lp with 8fgroshong catheter kit was returned.A visual and dimensional evaluation was performed.The stylet wire was noted to be approximately 37.5cm in length with a distinct break noted at the proximal end.The proximal end of the wire was not returned.A bend was noted approximately 12.5cm from the distal end and a slight bend was also noted approximately 1cm from the proximal end/break site.The break surface was unremarkable upon inspection.Therefore, the investigation can be confirmed for stylet wire break.Per the reported event details, the physician was not aware that the product contained a stylet wire during placement.While a definitive root cause could not be determined based upon available information, it is possible that procedural factors, including improper implant technique (i.E.Cutting the wire) contributed to the reported event.However, it is unknown if device handling and/or patient factors may have also contributed to the reported event.Mw5079058.
Event or Problem Description
It was reported that the port and stylet were implanted in the patient, as the physician was unaware the catheter had a stylet.One year later a ct revealed that the stylet had broken and migrated the renal vein.The stylet was removed successfully.There was no reported patient injury.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN VENOUS
• 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: 7835377
• Report Number: 3006260740-2018-02295
• Device Sequence Number: 11221408
• Product Code: LJT
• UDI-Device Identifier: 00801741026812
• UDI-Public: (01)00801741026812
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1718500
• Device Catalogue Number: 1718500
• Device Lot Number: REBT2337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 01/10/2019
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 11/06/2018; 01/16/2019
• 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
• Patient Age: 40 YR