MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP W/O SUTURE PLUGS, 9.6 FR SILICONE SL CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1859661
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
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.(expiry date: 9/2018).
Event or Problem Description
It was reported that approximately four months after port-a-catheter placement during infusion; the patient allegedly experienced pain and swelling.It was further reported that under evaluation with radiologist the catheter allegedly demonstrated a fracture and the broken segment was located in the superior vena cava.Reportedly, a week post evaluation the segment was removed.The following day the port was removed and replaced without complications.The patient was discharged home with instructions to follow up with oncologist.
Additional Manufacturer Narrative
Manufacturing review:the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged broken/migrated catheter as no objective evidence has been provided to confirm any alleged deficiency with the 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 flexural fatigue, catheter occlusion, and pinch off; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Labeling review: 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.(expiry date: 9/2018).
Event or Problem Description
It was reported that approximately four months after port-a-catheter placement during infusion; the patient allegedly experienced pain and swelling.It was further reported that under evaluation with radiologist the catheter allegedly demonstrated a fracture and the broken segment was located in the superior vena cava.Reportedly, a week post evaluation the segment was removed.The following day the port was removed and replaced without complications.The patient was discharged home with instructions to follow up with oncologist.

• Brand Name: POWERPORT MRI ISP W/O SUTURE PLUGS, 9.6 FR SILICONE SL CATHETER
• 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: 8308460
• Report Number: 3006260740-2019-00176
• Device Sequence Number: 18843805
• Product Code: LJT
• UDI-Device Identifier: 00801741027239
• UDI-Public: (01)00801741027239
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 1859661
• Device Catalogue Number: 1809661
• Device Lot Number: REBS0040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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: 41 YR