MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0602660
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a port placement procedure, the guidewire smoothly went inside but the sheath allegedly couldn't be pushed in over the guidewire.There was no reported patient injury.
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 bardport mri power port kit along with components were returned for sample evaluation.Visual, microscopic visual and functional evaluations were performed.The distal end of the peel-apart sheath was noted to be deformed, and the distal tip was noted to have a small crack by the edge.The distal tip of the vessel dilator was noted to be partially cracked on one edge.A kink was noted on the distal portion of the j-tip guidewire.An attempt to retract the loaded vessel dilator from the peel-apart sheath and an attempt to load the vessel dilator to the peel-apart sheath was performed and was successful without any issue.An attempt to load the j-tip guidewire to the peel-apart sheath and vessel dilator was performed and the guidewire successfully advanced through the dilator.Therefore, the investigation is confirmed for identified fracture and deformation.However, the investigation is inconclusive for the reported failure to advance issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.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 that during a port placement procedure the guidewire smoothly went inside, but the sheath allegedly couldn¿t be pushed in over the guidewire.It was further reported that additionally, internal jugular vein was getting injured which led to blood loss.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be reportable as serious injury.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 bard port mri power port kit along with components were returned for sample evaluation.Visual, microscopic visual and functional evaluations were performed.The distal end of the peel-apart sheath was noted to be deformed, and the distal tip was noted to have a small crack by the edge.The distal tip of the vessel dilator was noted to be partially cracked on one edge.A kink was noted on the distal portion of the j-tip guidewire.An attempt to retract the loaded vessel dilator from the peel-apart sheath and an attempt to load the vessel dilator to the peel-apart sheath was performed and was successful without any issue.An attempt to load the j-tip guidewire to the peel-apart sheath and vessel dilator was performed and the guidewire successfully advanced through the dilator.Therefore, the investigation is confirmed for identified fracture and deformation.However, the investigation is inconclusive for the reported failure to advance issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.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 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.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: 20380664
• Report Number: 3006260740-2024-05730
• Device Sequence Number: 7878290
• Product Code: LJT
• UDI-Device Identifier: 00801741025655
• UDI-Public: (01)00801741025655(11)230303(17)270630(10)REGZ3090
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 0602660
• Device Lot Number: REGZ3090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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 Sex: Unknown