MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 06/22/2023

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 (expiry date: 04/2025).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.H3 other text : device not returned.

Event Description

It was reported that during a port placement procedure via right internal jugular vein, the patient reportedly expired during cardiac arrest due to an air embolism.It was further reported that between the time removing dilator and inserting the catheter, air was drawn into the vessel, resulting in the patient developed an air embolism.The catheter should have been inserted immediately after removing dilator; however, the physician had not prepared the catheter in advance, and tip of sheath remained open for some time until inserting catheter.Reportedly, a head ct scan confirmed air accumulation in the brain.After thirty-fourty minutes of life support, the patient expired.No autopsy was performed, and the cause of death is unknown.

Event Description

It was reported that during a port placement procedure via right internal jugular vein, the patient reportedly expired during cardiac arrest due to an air embolism.It was further reported that between the time removing dilator and inserting the catheter, air was drawn into the vessel, resulting in the patient developed an air embolism.The catheter should have been inserted immediately after removing dilator; however, the physician had not prepared the catheter in advance, and tip of sheath remained open for some time until inserting catheter.Reportedly, a head ct scan confirmed air accumulation in the brain.After 30-40 minutes of life support, the patient expired.No autopsy was performed, and the cause of death is unknown.

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 physical device was not returned for evaluation.No photos or medical records were provided for review.Therefore, the investigation is inconclusive for any device issue as not evidence was provided for review.According to the reported event details, although the dilator was removed from the sheath the "physician had not prepared the catheter in advance, and tip of sheath remained open for some time until inserting catheter.Therefore, a use related issue can be confirmed as the user improperly left the sheath exposed for an extended time, contradicting the information provided in the instructions for use.This exposed device sheath is more likely to lead to the reported air embolism, and resulting patient expired.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 instructions for use was reviewed: according to the report, "during a port placement procedure, the sheath introducer within the kit (without air guard) was used.Between the time removing dilator and inserting the catheter, air was drawn into the vessel, resulting in the patient developed air embolism.Catheter should have been inserted immediately after removing dilator, but the physician had not prepared the catheter in advance, and tip of sheath remained open for some time until inserting catheter.After 30-40 minutes of life support, the patient died.No autopsy was performed, and the cause of death is unknown.Head ct scan confirmed air accumulation in the brain.It is thought that due to asd, the air entered into the vein was mixed to the artery, causing the patient died by entering large amount of air to the cerebral and pulmonary artery." therefore, the report alleges a use error.See the applicable instructions for use content below: "peel-apart sheath introducer instructions advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion.Advance it into the vein as a unit, leaving at least 2 cm of sheath exposed.Note: placement may be facilitated by making a small incision to ease introduction of vessel dilator and sheath introducer.Warning: avoid vessel perforation.Release the locking mechanism and gently withdraw the vessel dilator and ¿j¿ wire, leaving the sheath in place.Warning: for introducers, hold thumb over exposed opening of sheath to prevent air embolism.The risk of air embolism is reduced by performing this part of the procedure with the patient performing the valsalva maneuver." "warnings during placement: during placement through a peel-away introducer sheath, hold thumb over exposed opening of sheath to prevent air embolism.The risk of air embolism is reduced by performing this part of the procedure with the patient performing the valsalva maneuver." h10: d4 (expiry date: 04/2025), g3, h6 (device, method).H11: h6 (result, conclusion).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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 17332232
• MDR Text Key: 319103422
• Report Number: 3006260740-2023-02998
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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 Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: REGV0834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 35 KG