MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT MRI 8GS, INT. W SP, ATT S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1878000
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional 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.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, material separation and migration as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 approximately sometime post a port placement, the catheter allegedly fractured and migrated to the heart.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 device was not returned for evaluation.Medical records were provided and reviewed.Approximately two years and seven days post port placement, chest x ray revealed that left chest port tubing was fractured, long segment of tubing was situated in the heart traversing the right atrium and ventricle with a smaller section of tubing in the left axilla.Around three months and seventeen days later, fluoroscopic guided endovascular foreign body retrieval was performed.The patient also had a broken catheter that was largest in the pulmonary artery.Grams were obtained which demonstrate small amount of thrombus formation surrounding the foreign body that was lodged in the left lower lobe pulmonary artery.There was no thrombus surrounding the catheter in the right pulmonary artery.Using a 24 mm trilobed loop snare the tip of the catheter was snared and removed from the right common femoral vein.Successful foreign body retrieval from the third order pulmonary artery without complications.Next non-functioning and broken catheter found to be dislodged which was removed.On the same date, left subclavian chest port removal was performed.Fluoroscopic confirmation of a complete removal of the broken catheter was performed.Final images demonstrated any residual catheter in the left upper chest.The patient tolerated the procedure well and there were no complications.Successful removal of left-sided-sided subcutaneously implanted chest port.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: d4 (expiry date: 03/2023).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.H3 other text : device not returned.
Event or Problem Description
It was reported through litigation process that approximately two years and seven days later post port placement procedure, the port had fractured and migrated to heart.Reportedly, the patient developed thrombosis.However, the current status of the patient is unknown.

• Brand Name: POWERPORT MRI 8GS, INT. W SP, ATT S/L
• 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: 18569513
• Report Number: 3006260740-2024-00162
• Device Sequence Number: 12547687
• Product Code: LJT
• UDI-Device Identifier: 00801741027246
• UDI-Public: (01)00801741027246
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Catalogue Number: 1878000
• Device Lot Number: REDZ2311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 24 YR
• Patient Sex: Male