MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT

Catalog Number 0606150J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 03/01/2022

Event Type  Death  

Event Description

It was reported that during an echo guided port placement procedure in the internal jugular vein, about six months ago, the patient allegedly experienced an air embolism from the sheath before the catheter was inserted.The patient reportedly expired.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable ports that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port are identified in d2 and g4.As the lot number for the device was not provided, a review of the device history records could not 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.Date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.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.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable ports that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port are identified in d2 and g4.H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the air embolism through the device could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The following from the instructions for use may be useful in prevention of air embolism when using the introducer: "peel-apart sheath introducer instructions:.2.Release the locking mechanism and gently withdraw the vessel dilator and ¿j¿ wire, leaving the sheath in place.Warning: place thumb over exposed opening of sheath or needle or attach syringe filled with sterile normal saline solution to minimize blood loss and prevent air embolism.The risk of air embolism is reduced by performing this part of the procedure with the patient performing the valsalva maneuver and/ or in trendelenburg position.3.Insert catheter into the sheath.Advance the catheter through the sheath into the vessel to the desired infusion site." "when using an introducer kit, verify that the catheter fits easily through the introducer sheath." "bard access systems, inc.Recommends the use of components provided in the kit.If additional items are to be used, check for proper fit prior to utilization.Note: port body, catheter, and catheter-lock cannot be replaced with components outside the provided kit." 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 that during an echo guided port placement procedure in the internal jugular vein, about six months ago, the patient allegedly experienced an air embolism from the sheath before the catheter was inserted.The patient reportedly expired.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT
• Type of Device: IMPLANTABLE PORT
• 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: 15471217
• MDR Text Key: 300454121
• Report Number: 3006260740-2022-03697
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098253
• UDI-Public: (01)00801741098253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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: 0606150J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female