MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1809660

Device Problems Fracture (1260); Material Separation (1562); Dent in Material (2526); Deformation Due to Compressive Stress (2889); Migration (4003)

Patient Problems Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

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.D4 (expiry date: 10/2022).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 one year, two months, and twenty-two days post-port placement for breast cancer treatment, the port allegedly compressed, eroded, and pinched off.It was further reported that the port and an adjacent catheter segment were removed, but a piece portion of the catheter was allegedly found to have migrated to the patient's heart in the main pulmonary artery.Furthermore, a right heart catheterization was performed for foreign body retrieval from the pulmonary artery, and the catheter fragment was removed.Reportedly, the patient continued to experience left arm pain that radiated to the back and was diagnosed with chronic internal jugular vein thrombosis; however, the current status of the patent is unknown.

Manufacturer Narrative

H10: 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 not provided for review.Therefore, the investigation is inconclusive for the reported failure 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: b5, d4 (expiration date: 10/2022).H11: section a through f ¿ the information provided by bd represents all 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 the litigation process that one year, two months, and twenty-two days post-port placement for breast cancer treatment, during the port removal procedure, the port and an adjacent catheter segment were removed, but a piece portion of the catheter was allegedly found to have migrated to the patient's heart in the main pulmonary artery.Furthermore, a right heart catheterization was performed for foreign body retrieval from the pulmonary artery, and the catheter fragment was removed.Reportedly, the patient continued to experience left arm pain that radiated to the back and was diagnosed with chronic internal jugular vein thrombosis; however, the current status of the patient is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F
• 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: 17648534
• MDR Text Key: 322243828
• Report Number: 3006260740-2023-03787
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027154
• UDI-Public: (01)00801741027154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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: 1809660
• Device Lot Number: REFU1566
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/20/2023
• 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): Required Intervention
• Patient Sex: Female