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

Model Number 1808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problems Extravasation (1842); Pain (1994); Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

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.However, photos were provided for review.The investigation of the reported event is currently underway.Expiration date: 04/2025.

Event Description

It was reported that one year ten months and sixteen days post port device removal for a patient having rectal cancer, the catheter was allegedly fractured near the insertion site into the subclavian vein.It was further reported that, leakage of fluid allegedly happened from left chest port access site.Furthermore, the patient allegedly experienced discomfort during infusions and pain with palpation around the area of the port.Reportedly, the catheter was snared internally via common femoral vein access.The patient is well now.

Event Description

It was reported that one year ten months and sixteen days post port device removal for a patient having rectal cancer, the catheter was allegedly fractured near the insertion site into the subclavian vein.It was further identified that the port showed catheter perforation near the subclavian vein insertion site, leakage of fluid allegedly happened from left chest port access site while tried to remove the product.Furthermore, the patient allegedly experienced discomfort during infusions and pain with palpation around the area of the port.It was further reported that the port was attempted to be removed by outpatient surgery, but catheter perforation became a complete catheter fracture with a retained fragment located inside the patient¿s body.The patient was then transferred to vascular interventional radiology for retained foreign body retrieval.The user facility reported that the fractured catheter fragment had not embolized into the heart or pulmonary arteries; however, the decision was made to snare the fractured catheter and remove it from the femoral vein access site.The patient was reported to be well post-procedure.

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: one powerport isp mri implantable port attached to a groshong catheter in three segments was returned for evaluation.In addition to the returned physical sample, ten electronic photos were provided for review.All photos show one (1) powerport isp mri implantable port with a small segment of catheter still attached and two (2) other groshong catheter segments placed in a biohazard bag.Functional, gross visual, tactile, and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture, material separation, and fluid leak issues.A complete compound break was noted, about 14 cm from the distal end, which manifests variation in the texture of the break surfaces such that certain regions show smoothness/roundness and granularity in others.The lumen is compressed at both ends of this break and projections are noted, making the break significantly uneven.Some longitudinal cracking was also noted.Upon gently stretching each catheter, abnormal elasticity was felt throughout.Kinks were noted throughout both catheter segments.From the analysis of the sample as a whole, wear and kinking were also identified.The reported difficulty of removal cannot be directly confirmed from the samples returned.The identified break contains characteristics typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.It appears that the break was accelerated by the process of removal from the patient.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 04/2025).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.

• 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: 16459699
• MDR Text Key: 310422214
• Report Number: 3006260740-2023-00583
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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 Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REEX1379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White