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

Catalog Number CP00003

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problem Extravasation (1842)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 Description

It was reported that sometime post a port placement, the port was allegedly found to be fractured.It was further reported that the mid portion of the catheter allegedly leaked.Furthermore, the patient allegedly experienced extravasation as the chemo leaked into the soft tissue.Reportedly, the port was replaced.The current status of the patient was unknown.

Event Description

It was reported that one year, six months and thirteen days post a port placement in right internal jugular vein the catheter was allegedly found to be completely fractured.It was further reported that the mid portion of the catheter allegedly leaked towards the entry site at the jugular.Furthermore, the patient allegedly experienced extravasation as the chemo leaked into the soft tissue.Reportedly, the port was removed and replaced.The current status of the patient was unknown.

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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2024), g3, h6 (device) 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.

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: one power port implantable port attached to a groshong catheter in two segments were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A partial circumferential break was noted from the proximal end of the distal catheter segment.The edges of the partial circumferential break were noted to be uneven, and the surface was noted to be round and smooth in both regions.Upon infusion, a leak from the partial circumferential break on the catheter was observed.Kinks were noted throughout the distal catheter segment.Therefore, the investigation is confirmed for the reported fracture, fluid leak and the identified deformation and catheter wear issues.The break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking, of the catheter.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.

Event Description

It was reported that approximately one year, six months and thirteen days post a port placement in the right internal jugular vein, an alleged leak was identified via a venogram through the exiting catheter, towards the entry site, causing fluid to leak into the patient¿s soft tissue.It was further reported that the catheter was also observed to be completely fractured.The device was reportedly exchanged under fluoroscopy guidance and the procedure was completed without complications or significant blood loss.The patient recovered and was discharged home later that same day.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, GROSHONG, 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: 18948194
• MDR Text Key: 338187102
• Report Number: 3006260740-2024-01177
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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: CP00003
• Device Lot Number: REGS1968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/24/2024; Not provided
• Supplement Dates FDA Received: 05/21/2024; 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White