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 1878001

Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2023

Event Type  Injury  

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: 04/2024).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.H3 other text : device not returned.

Event Description

It was reported through litigation process that a port was placed in a patient after being diagnosed with breast cancer.It was further reported that one year, four months and five days post a port placement via the right jugular vein approach, the catheter was allegedly fractured at the proximal one by third level and the distal two third of the catheter was allegedly visualized in the right heart.Furthermore, the patient underwent attempted removal of foreign object and the longer sheath was advanced the snare under fluoroscopy guidance moderately attempt to snare the catheter was unsuccessful.Patient was referred to surgery.Patient underwent removal of port and removal of intracardiac foreign body.The current status of the patient is unknown.

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.The patient underwent mediport insertion procedure through right jugular vein approach under fluoroscopic technique.A 2 cm transverse incision was made below the right clavicle and a small subcutaneous pocket was made.A bard powerport was tunneled between the pocket and previous access site.The tip of the catheter confirmed to be at the superior vena cava and right atrium junction.The catheter was connected and locked on to the reservoir.A final fluoroscopic image was taken and confirmed good position and no catheter kinking.Chest x-ray was performed which showed tip of the mediport in the superior vena cava.No pneumothorax.Around one year and four months later, patient underwent fluoroscopy to evaluate the port for any leak.The study demonstrated a right chest mediport.There had been a fracture of the catheter at the proximal 1/3 level.The distal 2/3 of the catheter was visualized in the right heart.The need for complete catheter removal was discussed with the patient at the time of the study.Around one month later, patient underwent attempted removal of foreign object.The right neck area was prepped, and right internal jugular vein was accessed using ultrasound guided sheath was advanced.The longer sheath was advanced the snare under fluoroscopy guidance moderately, attempt to snare the catheter was unsuccessful.Patient was referred to surgery.Around three weeks later, patient underwent removal of mediport and removal of intracardiac foreign body.Intra-op pre-procedure transechocardiogram showed intra-cardiac mediport catheter was visualized.The previous mediport incision was reincised and the mediport was released from the pocket and removed.Only 1 cm length of the catheter was left attached to the mediport.The smooth lining of the mediport was excised.Then ultrasound guided right common femoral artery and vein access was obtained.A standard tip wire was introduced into the apex of the right ventricle.Then ensnare delivery catheter was introduced into the right ventricle apex.The tip of the right ventricle apex was able to be snared and carefully pulled back and out of the right internal jugular access site by removing the snare complex.The mediport incision was irrigated and closed in layers.Around nine days later, the pathology study of mediport demonstrated the mediport tip and consists of 14.1 cm in length and 0.2 cm in diameter portion of blue plastic tubing.No soft tissue was grossly identified.Therefore, the investigation is confirmed for the reported fracture, separation, migration and removal difficulty.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: 04/2024), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : device not returned.

Event Description

It was reported through litigation process that a port was placed in a patient after being diagnosed with breast cancer.It was further reported that one year, four months and five days post a port placement via the right jugular vein approach, the catheter was allegedly fractured at the proximal one by third level and the distal two third of the catheter was allegedly visualized in the right heart.Furthermore, the patient underwent attempted removal of foreign object and the longer sheath was advanced the snare under fluoroscopy guidance moderately attempt to snare the catheter was unsuccessful.Patient was referred to surgery.Patient underwent removal of port and removal of intracardiac foreign body.The current status of the patient is unknown.

• Brand Name: POWERPORT MRI 8GS, INT. W SP, ATT S/L
• Type of Device: 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: 19199425
• MDR Text Key: 341237562
• Report Number: 3006260740-2024-01940
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027253
• UDI-Public: (01)00801741027253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1878001
• Device Lot Number: REFT1522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female