MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1808561

Device Problems Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Shock (2072); Neck Pain (2433); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2013

Event Type  Injury  

Event Description

It was reported through litigation process that approximately two years later post port placement procedure, the port fractured and migrated.It was further reported that the patient was diagnosed with embolism, toxic shock and infection and the port was removed.The current status of the patient was unknown.

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.Furthermore, the clinical conditions 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.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.

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.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 that eight months and seventeen days post a port placement, the port fractured and migrated.It was further reported that the patient allegedly experienced neck pain and inflammation.It was also reported that the patient was diagnosed with embolism, toxic shock and infection.Reportedly, the port was removed and replaced with a new port.The current status of the patient was unknown.

Event Description

It was reported that eight months and seventeen days post a port placement via the left subclavian vein, the port was allegedly fractured and a small catheter fragment was allegedly found to be within the right hilar region.It was further reported that the patient allegedly experienced neck pain and inflammation.It was also reported that the patient was diagnosed with embolism, toxic shock and infection.Reportedly, the port was removed and replaced with a new port.The current status of the patient was 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.Approximately eight months and seventeen days post port placement, the port had stopped functioning and on the routine chest x-ray today, the radiologist had noted parts of it may have broken, a computed tomography showed missing piece.Chest x ray was taken since the prior to removal, a left sided port has either been retracted or fractured.There was a suspected fracture involving the distal most aspect of the catheter within the left chest.There was a small catheter fragment within the right hilar region.Further evaluation with a chest computed tomography with pulmonary embolism protocol was highly recommended.Around two days later, port was removed due to port malfunction and fracture.Around two months and two days later, a new mediport placement was performed.The left internal jugular medi port in place with its tip at the cavoatrial junction.Around three months and eighteen days later, concern raised for left chest mediport displacement from the previous night.Symptoms were attributed to previous dislodgement of catheter tip.New mediport was accessed using sterile technique and had a blood return.On the same day, computed tomography showed port tip was noted within the right atrium.Slightly asymmetric inflammatory changes were seen surrounding.Around four years and three months later, the patient presented for port flush, alert and oriented.Denied pain at this time.Left chest mediport was flushed with normal saline and heparin.Port was patent flushed with good blood return.Around six months and thirty days later, the patient had neck pain.The patient had mediport in left chest area.In past had mediport that had broken, and part ended up in lung.Around five days later, the patient stated that the previous mediport inserted had problems as the tip broke off in the patient¿s lungs.The patient stated that the pain was similar to previous situation.The pain increased when moving the neck.The patient admits of having redness in location of mediport.Around five years and two months later, due to rib fracture the patient had pain with inspiration.The left internal jugular port-a-cath has been removed.There was a small, retained catheter fragment in the right perihilar region that was unchanged from last six years.Therefore, the investigation is confirmed for the reported fracture, material separation and migration issue.Additionally, it can be confirmed that the patient experienced embolism, infection, inflammation, neck pain post port placement.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: b5, 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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 18424364
• MDR Text Key: 331776929
• Report Number: 3006260740-2023-05962
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027123
• UDI-Public: (01)00801741027123
• 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,Followup
• Report Date: 05/14/2024

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: 1808561
• Device Lot Number: REVK0080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 05/14/2024
• Supplement Dates FDA Received: 04/13/2024; 05/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 30 YR
• Patient Sex: Female