MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD VACCESS CT POWERPORT WITH 8F CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	7380000
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.The return of the device is pending.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that thirteen days after port placement, imaging demonstrated catheter separated from the port and migrated to the right ventricle.It was further reported that the catheter was removed.One week later the port was removed and another port was placed.The patient handled the replacement procedure well and was discharged the same day.
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: one segment of catheter was returned for evaluation.The distal end of the catheter ends in a complete compound break, segment distal to this break was not returned for evaluation.The break is characterized by longitudinal breaks and rough surfaces.As no specific break could be identified, the investigation is confirmed for a subcutaneous break with embolization.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 damaged during implantation, flexural fatigue, and pinch-off.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.
Event or Problem Description
It was reported that thirteen days after port placement, imaging demonstrated catheter separated from the port and migrated to the right ventricle.It was further reported that the catheter was removed.One week later the port was removed and another port was placed.The patient handled the replacement procedure well and was discharged the same day.

• Brand Name: BARD VACCESS CT POWERPORT WITH 8F 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: 8189379
• Report Number: 3006260740-2018-03715
• Device Sequence Number: 2027235
• Product Code: LJT
• UDI-Device Identifier: 00801741027451
• UDI-Public: (01)00801741027451
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 7380000
• Device Catalogue Number: 7380000
• Device Lot Number: RECV0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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: 71 YR
• Patient Weight: 63