MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERPORT MRI ISP WITH 8FR GROSHONG CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.The lot number for the device was not provided, therefore, the device history records were not reviewed.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately three and half years post port implantation via right subclavian vein, the catheter allegedly fractured near the insertion site.It was further reported that the catheter migrated and was removed.The current patient status is unknown.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one mri powerport isp with 8fr groshong catheter was received for evaluation.Visual inspection identified a complete compound break near the 8cm depth marker.Microscopic investigation showed the break surface was granular.Therefore, the investigation is confirmed for the alleged break with embolism.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.

Event Description

It was reported that approximately three and half years post port implantation via right subclavian vein, the catheter allegedly fractured near the insertion site.It was further reported that the catheter migrated and was removed.The current patient status is unknown.

• Brand Name: BARD POWERPORT MRI ISP WITH 8FR GROSHONG CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8200870
• MDR Text Key: 131543458
• Report Number: 3006260740-2018-03754
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1