MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870C

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

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo and images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2025).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 pending return.

Event Description

It was reported that approximately seven years post a port placement, the port catheter was allegedly found to be fallen off to the right atrium under a fluoroscopic examination and the patient experienced chest pain.It was further reported that an emergency interventional surgery was performed to remove the catheter and a contrast catheter was used to repeatedly push the port catheter into the pulmonary artery or pull it into the right atrium under fluoroscopy but was unsuccessful.It was also reported that a retrieval device was further used to grab the infusion port catheter again but was unsuccessful.Furthermore, position of the catheter and the condition of the pulmonary blood vessels were evaluated under chest computed tomography and was found that the catheter was located in the pericardial cavity and was found to be detached.Reportedly, thoracoscopic-assisted thoracotomy was performed to remove the port catheter and during removal a small amount of old infusion port catheter was seen in the pericardium, touched behind the right ventricle, and the right ventricular myocardium was partially contused due to catheter penetration.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f are identified in d2 and g4.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 sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one groshong catheter segment.The investigation is inconclusive for the reported fracture, material separation, migration and difficult to remove issue as no objective evidence was obtained from the provided photo.The definitive root cause could not be determined based upon available information.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: 10/2025), g3, h6 (method).H11: h6 (result, conclusion).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 approximately seven years post a port placement, the port catheter was allegedly found to be fallen off to the right atrium under a fluoroscopic examination and the patient experienced chest pain.It was further reported that an emergency interventional surgery was performed to remove the catheter and a contrast catheter was used to repeatedly push the port catheter into the pulmonary artery or pull it into the right atrium under fluoroscopy but was unsuccessful.It was also reported that a retrieval device was further used to grab the infusion port catheter again but was unsuccessful.Furthermore, position of the catheter and the condition of the pulmonary blood vessels were evaluated under chest computed tomography and was found that the catheter was located in the pericardial cavity and was found to be detached.Reportedly, thoracoscopic-assisted thoracotomy was performed to remove the port catheter and during removal a small amount of old infusion port catheter was seen in the pericardium, touched behind the right ventricle, and the right ventricular myocardium was partially contused due to catheter penetration.The current status of the patient is unknown.

• Brand Name: GROSHONG PORT SINGLE LUMEN
• 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: 18523842
• MDR Text Key: 332974409
• Report Number: 3006260740-2024-00087
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 0603870C
• Device Lot Number: REGY2386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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: 67 YR
• Patient Sex: Male