MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1806061

Device Problems Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/2022

Event Type  Death  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records 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.H10: d4 (expiration date: 12/2021) h11: section a through f - the information provided by bd 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 bd.Device not returned.

Event Description

It was reported that ten days post port removal due to broken/fragmented pieces, the male patient died of acute hypoxic respiratory failure and pneumonia.The implant date was reported to be on or about (b)(6) 2021, the port allegedly broke/fragmented and thereby removed on (b)(6) 2022, the patient expired (b)(6) 2022.Additional information is being obtained to understand the relatedness of the device to the death.

Manufacturer Narrative

H10: 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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.These described that, about a month after port placement, chest x ray showed that the port catheter had separated from the port and the tip was in the pulmonary artery and the peripheral and was in the left innominate vein.Also, a short separation was also present on the chest x ray from several days prior but was very difficult to see.The patient had neutropenic fever.The catheter was retrieved.These events are therefore confirmed.However, the medical record does not allow confirmation of the reported patient infection or death.Sterilization records for this lot and applicable lal/bioburden information were reviewed and no issues were identified.A definitive root cause for these events, including their relationship to the port device, could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, therefore a labeling review is not required.H10: d4 (expiration date: 12/2021), g2, g3, h6 (patient, device, method).H11: b3, b5, e1, h6 (result).H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported through the litigation process that approximately one month and eight days post a port placement via the left internal jugular vein, the port catheter was allegedly found to be separated from the port and the tip was found to be in the pulmonary artery and the peripheral and was in the left innominate vein.It was further reported that the catheter fragments were removed percutaneously and the port was removed from the patient.Reportedly, the patient died of acute hypoxic respiratory failure and pneumonia.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18461081
• MDR Text Key: 332251054
• Report Number: 3006260740-2023-06051
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1806061
• Device Lot Number: REEX3955
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2020
• 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
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Male