MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1706061
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); Thrombosis/Thrombus (4440)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.D4 (expiration date: 12/2022).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 three months and four days post a port placement, the patient reportedly diagnosed with fibrin sheath formation around the tip of the port catheter.It was further reported that patient allegedly developed with thrombosis, infection and sepsis.Reportedly, the patient was treated with antibiotics and the infected port was removed.The current status of the patient is unknown.
Event or Problem Description
It was reported through the litigation process that three months and four days post a port placement, the device allegedly migrated the patient reportedly diagnosed with fibrin sheath formation around the tip of the port catheter.It was further reported that patient allegedly developed with thrombosis, infection and sepsis.Reportedly, the patient was treated with antibiotics and the infected port was removed.The current status of the patient is unknown.
Additional 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.Medical records were provided and reviewed.Approximately three months post port placement, a fluoroscopy study showed that the positioning of the right internal jugular vein chest port was suboptimal.The catheter tip projected over expected location of the confluence of the right internal jugular vein and subclavian vein.There was fibrin sheath surrounding the catheter.There was reflux of contrast along the catheter back into the internal jugular vein cranially.There was flow artifact surrounding the internal jugular vein just below the access site in the internal jugular vein that could represent clot.Around four days later, patient admitted to hospital for neutropenic fever.Started on intravenous fluids, vancomycin and cefepime per sepsis protocol.General surgery was consulted for malpositioned port and advised for removal and replacement.The same day, patient underwent x-ray chest for fever.The study showed that right sided internal jugular approach medi port was present and appeared similar to prior imaging with the tip in the region of the brachiocephalic vein.The next day, patient underwent ultrasound duplex right upper extremity vein study for swelling of limb.The study showed deep vein thrombosis present within the right internal jugular vein.An ultrasound chest showed no definite fluid demonstrated adjacent to the port.Around six days later, patient underwent port explant procedure.The port and catheter were removed with catheter intact.The patient tolerated the procedure well.Patient was treated with antibiotics and discharged home.Therefore, the investigation is confirmed for the reported migration and fibrin sheath formation.Furthermore, the clinical conditions alleged in the complaint can 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, g3, h6 (device, 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.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• 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: 19496744
• Report Number: 3006260740-2024-02893
• Device Sequence Number: 7973071
• Product Code: LJT
• UDI-Device Identifier: 00801741026553
• UDI-Public: (01)00801741026553(11)210304(17)221231(10)REFN3373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/01/2024

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: 12/31/2022
• Device Catalogue Number: 1706061
• Device Lot Number: REFN3373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• 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: 67 YR
• Patient Sex: Female