MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 7F GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0603870
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/14/2018
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.
Event or Problem Description
It was reported that approximately ten months post port system placement in the right internal jugular for chemotherapy treatment of colon cancer, the catheter allegedly migrated into the lung identified via ct scan.It was further reported that the catheter was removed.The patient status is unknown post removal procedural.
Event or Problem Description
It was reported that approximately ten months post port system placement in the right internal jugular for chemotherapy treatment of colon cancer, the catheter allegedly migrated into the lung identified via ct scan.It was further reported that the catheter was removed.The patient status is unknown post removal procedural.
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.Investigation summary: one mri lp port and cath lock were returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for catheter break, as no fragments from the catheter were returned.The port appeared to have been used, as there were multiple punctures to the port septum.The port body was patent to infusion and aspiration.The definitive root cause could not be determined based upon available information.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.
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.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 catheter embolization 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 over-pressurization, flexural fatigue, 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.
Event or Problem Description
It was reported that approximately ten months post port system placement in the right internal jugular for chemotherapy treatment of colon cancer, the catheter allegedly migrated into the lung identified via ct scan.It was further reported that the catheter was removed.The patient status is unknown post removal procedural.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 7F GROSHONG
• 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: 8464973
• Report Number: 3006260740-2019-00722
• Device Sequence Number: 11510576
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2019

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: 0603870
• Device Catalogue Number: 0603870
• Device Lot Number: REAW1019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 07/25/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/03/2019; 07/29/2019
• 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