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

Catalog Number 1808001

Device Problems Fracture (1260); Blocked Connection (2888); Expulsion (2933)

Patient Problems Chest Pain (1776); Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/21/2015

Event Type  Injury  

Event Description

It was reported through litigation process that sometime post a port placement, the port allegedly fractured, and the port eroded.It was further reported that patient allegedly developed infection and alleged having chest pain.However, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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.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.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and six months post third port placement, the patient presented with open wound at powerport and presented with drainage from her powerport right chest and also noted to have difficult access.Around eight days later, removal of existing port and new mri powerport placement was planned and completed successfully.Approximately two years and six months post fourth port placement, x ray port revealed that the port was malpositioned.Around seven days later, the removal of right subclavian vein powerport was planned and placement of left internal jugular vein bard powerport was done successfully.Approximately three years and two months post fifth port placement, x ray of port revealed malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.Around eleven days later, placement of left subclavian bard powerport and removal of left internal jugular vein powerport was planned.New port was placed successfully.The patient was taken in stable condition.Therefore, the investigation is inconclusive for the reported fracture and expulsion as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g2, g3, h6 (patient, method) h11: b3, b5 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 through litigation process that three years six months eighteen days post port placement, the port fractured, port eroded.It was further reported that patient developed infection and alleged having chest pain and also presented with open wound and drainage at port site.However, the current status of the patient is unknown.

Event Description

It was reported through litigation process that three years, six months and twenty-six days post a port placement via the right subclavian vein, the port was allegedly fractured and eroded.It was further reported that the port was allegedly noted to have a poor venous access.Furthermore, the patient developed infection and allegedly had chest pain and also presented with an open wound with serious drainage at the port site.Reportedly, the port was removed and replaced.However, the current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and six months post third port placement, the patient presented with open wound at powerport and presented with drainage from her powerport right chest and also noted to have difficult access.Around eight days later, removal of existing port and new mri powerport placement was planned and completed successfully.Approximately two years and six months post fourth port placement, x ray port revealed that the port was malpositioned.Around seven days later, the removal of right subclavian vein powerport was planned and placement of left internal jugular vein bard powerport was done successfully.Approximately three years and two months post fifth port placement, x ray of port revealed malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.Around eleven days later, placement of left subclavian bard powerport and removal of left internal jugular vein powerport was planned.New port was placed successfully.The patient was taken in stable condition.Therefore, the investigation is confirmed for the reported blocked connection based on the medical records.However, the investigation is inconclusive for the reported fracture and expulsion as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 M.R.I. IMPLANTABLE PORT, CHRONOFLEX 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: 18500768
• MDR Text Key: 332723872
• Report Number: 3006260740-2023-06126
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026980
• UDI-Public: (01)00801741026980
• 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,Followup
• Report Date: 04/18/2024

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: 1808001
• Device Lot Number: REWA1050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/26/2024; 04/16/2024
• Supplement Dates FDA Received: 03/01/2024; 05/10/2024
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female