MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1829570
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that four months and fourteen days post a port placement, the patient allegedly developed with right arm swelling.Furthermore, the patient was allegedly diagnosed with right subclavian and axillary venous thrombosis under ultrasound imaging of right upper extremity.Reportedly, the catheter and port were removed in its entirety and discarded.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2023).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.
Additional 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.Medical records alleged that the patient underwent port placement procedure for treatment of left breast mass.Procedure was completed and fluoroscopic imaging was used to confirm correct placement.Dual lumen power port was attached to the catheter and the port placed in the pocket.The port aspirated and flushed with heparinized saline without issue.Approximately four months seventeen days later patient presented to office visit.Three days before visit she had blood drawn from right antecubital and she was difficult stick and developed right arm swelling below the site of iv stick.She states her hand swelling has decreased but her arm remains swollen.She was advised to apply vaseline to skin twice a day after shower and referred to radiation oncology.Next day patient underwent ultrasound venous doppler right upper extremity study showed right subclavian and axillary venous thrombosis.Approximately one month eight days post ultrasound patient underwent echocardiogram which showed normal left ventricle without any hypertrophy.There was trivial to mild tricuspid valve regurgitation.There was trivial to mild aortic valve regurgitation.After three days patient underwent x shaped localization clip in the upper outer left breast.Next day patient underwent ultrasound venous duplex of right upper extremity which showed no evidence of acute deep vein thrombosis in the right upper extremity.After one day patient underwent left breast lumpectomy with savi location and left axillary sentinel lymph node biopsy along with right medi port removal.Local anesthetic was infused, incision was made and medi port was dissected free.Then placed in reverse trendelenberg and the catheter and port were removed in its entirety and discarded.Therefore, the investigation is confirmed for the reported thrombosis and swelling.Furthermore, clinical conditions alleged in the complaint can be confirmed.Based upon available information, the definitive root cause was unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method) h11: d4 (unique identifier (udi) #), h6 (result, conclusion) 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 or Problem Description
It was reported through the litigation process that four months and fourteen days post a port placement, the patient allegedly developed with right arm swelling.Furthermore, the patient was allegedly diagnosed with right subclavian and axillary venous thrombosis under ultrasound imaging of right upper extremity.Reportedly, the catheter and port were removed in its entirety and discarded.The current status of the patient is unknown.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• Common Device Name: 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: 20144004
• Report Number: 3006260740-2024-04937
• Device Sequence Number: 15529139
• Product Code: LJT
• UDI-Device Identifier: 00801741027192
• UDI-Public: (01)00801741027192(17)230531(10)REFV0272
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 1829570
• Device Lot Number: REFV0272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female