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

Catalog Number 1759600

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

Patient Problems Arrhythmia (1721); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/27/2021

Event Type  Injury  

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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that five months and seventeen days post port placement via the right subclavian vein, the port was allegedly found to be fractured.It was further reported that a piece had broken off and migrated to the patient's heart.Furthermore, attempts were made to remove the fractured piece and the rest of the remaining product but were unsuccessful in removing the defective device in its entirety due to the developing heart arrhythmias during the procedure.Reportedly, additional surgery was done to remove the fractured catheter piece.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that five months and seventeen days post port placement via the right subclavian vein, the port was allegedly found to be fractured.It was further reported that a piece had broken off and migrated to the patient's heart.Furthermore, attempts were made to remove the fractured piece and the rest of the remaining product but were unsuccessful in removing the defective device in its entirety due to the developing heart arrhythmias during the procedure.Reportedly, additional surgery was done to remove the fractured catheter piece.The current status of the patient is unknown.

Manufacturer Narrative

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.The definitive root cause could not be determined based upon the available 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.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.

Event Description

It was reported through the litigation process that five months seventeen days post port placement for cancer treatment, the port allegedly fractured.It was further reported that a piece had broken off and migrated to patient heart.The patient was developed with heart arrhythmia during the removal procedure.Further an additional surgery was done to remove to fractured catheter piece.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 provided and reviewed.Approximately five months and nineteen days post port placement, a ct of chest was performed which demonstrates the catheter fragment appearing to be within the right ventricle.Patient underwent ultrasound guided right common femoral vein access, a right chest port was removed and attempted foreign body retrieval procedure.On the same day the patient was placed on right new powerport clearvue slim placement with new venous access and port pocket.A referral was made to cardiothoracic surgery for evaluation of a retained catheter fragment in the right ventricle.Patient condition was stable and discharged to home.Therefore, the investigation is confirmed for the reported fracture, material separation and migration.Furthermore, the clinical condition 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: a1, a3, d4 (expiration date: 05/2022), g2, g3, h6 (method) h11: b5, b7, d1, d4, h6 (result) 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.

• Brand Name: POWERPORT 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: 17389414
• MDR Text Key: 319757285
• Report Number: 3006260740-2023-03158
• Device Sequence Number: 1
• Product Code: LJT
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2024

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: 1759600
• Device Lot Number: REEV1030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 09/20/2023; 02/02/2024
• Supplement Dates FDA Received: 09/23/2023; 02/25/2024
• 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: 65 YR
• Patient Sex: Female