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	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994)
Date of Event	08/28/2024
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: (expiry date: 09/2025).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 that seven months and four days post a port placement, the port was allegedly broken in patient.It was further reported that leak was also observed.Reportedly, fractures identified with contrast extravasation tracking retrograde along the catheter into the port reservoir.The current status of the patient was 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: one powerport mri implantable port and a groshong catheter in two segments were received for evaluation.A complete circumferential break was noted on the proximal end of the proximal catheter segment and a complete compound break was noted on the distal end of the proximal catheter segment that was elliptical in shape.The distal catheter segment was returned and measured approximately 11.7cm in length and a complete compound break was noted on the proximal end of the distal catheter segment that was elliptical in shape.The edges of the complete compound break on the distal end of the proximal catheter segment were noted to be uneven.The surface was noted to be granular throughout.Therefore, the investigation is confirmed for the reported fracture, leak and identified material separation, wear and deformation issues.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: 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.
Event or Problem Description
It was reported that seven months and four days post a port placement, the port catheter was allegedly broken in patient.It was further reported that a fluid leak was also allegedly observed.Furthermore, after the installation of contrast, contrast was identified at the tip of the catheter; however, at the intersection of the first rib and the clavicle, a fracture was allegedly identified with contrast extravasation tracking retrograde along the catheter into the port reservoir under x-ray examination.Moreover, the patient allegedly experienced shoulder pain.Reportedly, a surgery was performed to remove the port catheter.The current status of the patient was 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: 20331370
• Report Number: 3006260740-2024-05581
• Device Sequence Number: 8096886
• Product Code: LJT
• UDI-Device Identifier: 00801741027246
• UDI-Public: (01)00801741027246(11)231003(17)250930(10)REHU3371
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 09/30/2025
• Device Catalogue Number: 1878000
• Device Lot Number: REHU3371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White