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	Pulmonary Embolism (1498); Unspecified Infection (1930)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
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 (expiry date: 12/2099).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 or Problem Description
It was reported through litigation process that two years, four months and sixteen days post a port placement in the right internal jugular vein, the patient allegedly developed with infection and pulmonary embolism secondary to port.It was further reported that the port was removed.However, the current status of the patient is unknown.
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 physical device was not returned for evaluation.Medical records were provided for review.The patient underwent port (lot no: rebr1413, model no: 1829570) placement procedure for treatment of acute leukemia.Tract was dilated in the usual fashion and subcutaneous tunnel was created below the level of the clavicle.Then dual lumen power chest port was fitted to the subcutaneous pocket and catheter pulled through the tunnel, cut to the appropriate length and the tip was fluoroscopically placed into the high right atrium on deep inspiration.Then, the port was secured in the subcutaneous pocket with sutures.Two years later, a computed tomography angiogram of chest was performed for pleuritic chest pain and elevated d-dimer.The study showed small pulmonary emboli in the subsegmental right lower lobe and segmental left lower lobe branches of the pulmonary artery.No evidence of pulmonary infarct or right heart strain.Again, a chest x-ray was performed for chest pain.The study showed right chest wall port with tip terminating in the region of the cavoatrial junction and the patient underwent port removal procedure for thrombophilic port.Patient was found to have multiple pulmonary emboli likely secondary to his port.The port and catheter were removed intact, while pressure was held just superior to the clavicle, compressing the right internal jugular vein.Therefore, the investigation is confirmed for the reported pulmonary embolism issue.However, infection alleged in the complaint cannot be confirmed from the provided medical record.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 12/2099), g3, h6 (method).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 litigation process that two years, four months and sixteen days post a port placement in the right internal jugular vein, the patient allegedly developed with infection and pulmonary embolism secondary to port.It was further reported that the port was removed.However, 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: 19770329
• Report Number: 3006260740-2024-03856
• Device Sequence Number: 12942905
• Product Code: LJT
• UDI-Device Identifier: 00801741027192
• UDI-Public: (01)00801741027192
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K090512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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 Catalogue Number: 1829570
• Device Lot Number: REBR1413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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: 31 YR
• Patient Sex: Male
• Patient Race: White