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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the catheter was allegedly fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, as no objective evidence was provided for review.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.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.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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.The medical record states that the implantable port was implanted to a patient for the treatment of malignant melanoma and the port was placed after right axillary lymph node dissection.The port placement procedure was undertaken with the help of ultrasound guidance, a large bore needle was accessed in left jugular vein, the guide wire was threaded down the needle towards the heart.A port pocket was created by incision over the skin at the left side of the chest, and the catheter was tunneled from the neck to chest wall.Further, the catheter was trimmed to its appropriate length and attached to the port.The placed port was sutured to the chest wall.Finally, the implanted port was flushed, aspirated, and cleaned.Fluoroscopy confirms the position of port and catheter without any sharp bend.Approximately after three years and four months later, an chest x-ray was performed to check the status of the implanted port, it was observed that the catheter fragment was within the right ventricle.However, the previous radiography which was taken after three years and two months later of post implant showed that the port and catheter were located in satisfactory position.After a week of chest x-ray taken, the port removal procedure was undertaken with the help of ultrasound and fluoroscopic guidance, foreign body removal at the right jugular vein.The guide wire was advanced at the level of inferior vena cava, the transitional catheter and stylet was removed.Through the sheath in ensnare device, the fragmented catheter was snared and removed through the dermatotomy site.A final image demonstrates there is no radiopaque foreign body left behind within the neck and chest.As the medical record confirms the evidence, catheter fracture, catheter separation and catheter migration, therefore the investigation confirms the same for the reported events.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 (expiration 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.
Event or Problem Description
It was reported through the litigation process that three years, five months, and eight days post a port placement via the left internal jugular vein, the catheter was allegedly fractured.It was further reported that the fractured catheter fragment had allegedly migrated within the patient's right ventricle.Reportedly, the retained portion of the fractured catheter fragment was retrieved with a snare device.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: 18835620
• Report Number: 3006260740-2024-00915
• Device Sequence Number: 7227023
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: REDY3929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/08/2024
• 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: 69 YR
• Patient Sex: Male