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

Catalog Number 9808560

Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2021).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 seven years and twelve days post a port placement via right internal jugular vein approach for the purpose of chemotherapy for uterine cancer, the two tears allegedly occurred on the catheter, one at twelve centimeter from the tip of the catheter and other just above from the stem of the port.It was further reported that the catheter fragment from the right atrium to the right ventricle.It was further reported that the catheter was allegedly difficult to be removed from the patient.Reportedly, a tear in the catheter was allegedly caused by a kink in the internal jugular vein.The current status of the patient is unknown.

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 implantable port attached to a groshong catheter in two segments and a cath-lock were returned for sample evaluation.Functional, gross visual, tactile, dimensional and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter and segment was measured approximately 8.9cm in length.The proximal segment of the catheter was noted to be separated from the port body and had splits.Complete circumferential breaks were noted on both ends of the distal catheter segment.The edges of the complete circumferential break on the distal end of the catheter and proximal end of distal catheter segment were noted to be uneven and the surface was noted to be round and smooth on one region and granular in the other region and distal end catheter segment were noted to be jagged.Splits were noted on border of the surface.Upon the infusion and aspiration on port and on distal catheter segment was attempted and successful without issue.No leak was noted.Therefore, the investigation is confirmed for the reported fracture, deformation, material separation and identified wear and improper or incorrect procedure issue.However, the investigation is inconclusive for the reported migration, difficult to remove issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.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.Instructions for use reviewed: the instructions for use states that flushing volumes: when port not in use - 5 ml heparinized saline every 4 weeks.H10: b5, d4 (expiration date: 01/2021), g3, h6 (device) h11: h6 (method, 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.H3 other text : see h10.

Event Description

It was reported that seven years and twelve days post a port placement via the right internal jugular vein, two tears allegedly occurred on the catheter, one at twelve centimeter from the tip of the catheter and the other just above from the stem of the port.It was further reported that the fractured catheter fragment had allegedly migrated from the right atrium to the patient's right ventricle.Furthermore, the catheter was allegedly difficult to be removed from the patient.Moreover, a tear in the catheter was allegedly caused by a kink in the internal jugular vein.Reportedly, the port system was removed.The current status of the patient is unknown.

• 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: 18490550
• MDR Text Key: 332603049
• Report Number: 3006260740-2024-00061
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9808560
• Device Lot Number: REAT2698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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 Sex: Female