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

Catalog Number 1808060

Device Problems Suction Problem (2170); Material Twisted/Bent (2981)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  Injury  

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.The investigation is inconclusive for the reported material twist as no objective evidence has been provided.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.

Event Description

It was reported that sometime post a port placement, the catheter was allegedly coiled within the patient's neck.There was no reported patient injury.

Event Description

It was reported that four months fourteen days post a port placement procedure, the catheter allegedly had suction problem and the catheter allegedly coiled within the patient's neck.It was further reported that the patient had pain over the port area and developed with thrombus and thrombosis.However, the port was removed and new port has been implanted.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 physical device was not returned for evaluation.Medical records was provided and reviewed.The review states the bard implantable port was implanted to the left clavicle of chest by advancing the wire into the right and left subclavian veins with the help of fluoroscope, the port was tunneled and placed in the incision pocket at the subclavian area.Approximately after five months later patient was suffered from the chest pain and shortness of breath, the patient has also had the history of thrombus at ij level, within the same day the chest x-ray was performed.It was observed that the port-a-cath remains present via left jugular approach distal tip projected adjacent to the aortic knob is grossly unchanged significantly compared to prior exam.During the observation the catheter portion was incompletely viewed to the most superior extent.On the next day the patient was underwent general surgery for port malfunction and pain over port.It was further noted that blood was unable to get from the port due to the thrombus.A computer tomography of chest with contrast was performed suspected for pulmonary embolism and no evidence of pulmonary embolus.Thrombus was observed over the surrounding of left ij catheter with vague density of soft tissue.Three days later the patient was having pain over the port and neck and unable to draw the balloon.The patient was on port associated thrombus, left side of the port has been malfunctioned.Under x-ray the catheter is noted to be shorten and coiled within the neck.It was planned replace with a new tunneled port due to the port malfunction.A new port was placed over the right chest and able to perform the port's intended use and the malfunctioned port on the left side of the chest was remove completely.Based on the submitted medical record review was it confirmed the catheter is noted to be coiled around the neck region of the patient and unable to draw the blood from the port.Hence the investigation was confirmed for the reported catheter twisting and suction problem.Additionally, it can be confirmed that the patient experienced thrombus and thrombosis.However, the relationship to the port is unknown.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: 07/2023), g2, g3, h6 (device, method).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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX 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: 18370706
• MDR Text Key: 331055568
• Report Number: 3006260740-2023-05784
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027031
• UDI-Public: (01)00801741027031
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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: 1808060
• Device Lot Number: REFX4082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/23/2024
• 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: 69 YR
• Patient Sex: Female