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

Catalog Number	0607550
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Blocked Connection (2888); Migration (4003)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pneumothorax (2012); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/22/2014
Type of Reportable Event	Serious Injury
Additional 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.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 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 or Problem Description
It was reported through litigation process that sometime post a port placement, the catheter allegedly fractured and migrated to the heart.It was further reported that patient allegedly developed blood clots, pulmonary embolism and experienced lung puncture.However, the current status of the patient is unknown.
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: the device was not returned for evaluation.Seven electronic photos were provided and reviewed.The first and sixth photo shows the partial view of the catheter tubing.The second and fifth photo shows a biohazard specimen bag in which a catheter segment is noted.The third photo shows the x-port isp with the catheter tubing in which cathlock noted to be placed in correct position.The fourth photo shows the upside-down view of the port.The seventh photo shows the patient identification card in which patient and product information are given which was verified and matches with trackwise details.No other visual anomalies were noted.Medical records were provided and reviewed.Approximately two months and twenty-eight days post port placement, patient presented to the medical consultation for malfunctioning port.There was hard time accessing the port and flushing the port.It was noted possible broken piece going to the pulmonary artery in vap contrast study.A ct abdomen and chest which showed 15 mm broken catheter fragment extending from the right main pulmonary artery to the left lobe of pulmonary artery branch.Incidental finding of small non occlusive thrombi in 2 branches of the left lower lobe pulmonary artery is most likely from catheter in pulmonary artery.An x-ray fluoroscopic study showed fractured left subclavian venous access port with an 18 cm catheter fragment within the main pulmonary artery and right main pulmonary artery.So, the port not used for infusion.Removal of the catheter under guidance of interventional radiology was planned.On the same day, patient underwent pulmonary angiogram and foreign body catheter retrieval procedure.Through the ultrasound guidance, a catheter was placed into the right atrium.A limited pulmonary arteriogram was performed.The catheter fragment could not be snared from the left side due to the distal placement of the catheter.The sheath and snare fragment complex were removed in total.Around six days later, patient admitted for excision of vascular access port with previous fracture and reinsertion of vascular access port.New port was placed.X-ray chest was performed which showed a new left chest port with tip to the upper superior vena cava.The course of the catheter is somewhat atypical but likely enters the subclavian vein.Therefore, the investigation is confirmed for the reported fracture, material separation, migration, blocked connection and difficult to flush.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.H10: d4 (expiry date: 06/2018), g2, g3, h6 (device, method) h11: b3, b5, d4 (medical device lot number), h6 (patient, result) 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.H3 other text : device not returned.
Event or Problem Description
It was reported through the litigation process that two months and twenty-eight days post a port placement, there was difficulty in accessing and flushing the port.It was further reported that under an x-ray examination, the port was allegedly found to be fractured with an eighteen centimeter of the catheter fragment extended from the right main pulmonary artery to the left lobe of pulmonary artery branch.Furthermore, the patient allegedly experienced a small nonocclusive thrombi in two branches of left lower lobe pulmonary artery which was likely from the catheter in the pulmonary artery.Reportedly, the catheter fragment was snared out and the port was removed and replaced.The current status of the patient was unknown.

• Brand Name: X-PORT ISP 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: 18569569
• Report Number: 3006260740-2024-00161
• Device Sequence Number: 17932045
• Product Code: LJT
• UDI-Device Identifier: 00801741026195
• UDI-Public: (01)00801741026195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: 0607550
• Device Lot Number: REXE1706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MULTI-VITAMIN AND VITAMIN B12; XANAX, VITAMIN D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: White