MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG PORT S/L CHINA ONLY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870C

Device Problems Break (1069); Fracture (1260); Material Separation (1562)

Patient Problem Injury (2348)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review 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.

Event Description

It was reported that approximately two years and one month post port placement in the left chest wall via left internal jugular vein, a chest radiography allegedly demonstrated a catheter rupture.Reportedly, the catheter remained in the atrium and ventricle.It was further reported that the port and catheter were removed under digital subtraction angiography (dsa).The patient remained in the hospital for one week.There were no further reported complications.

Manufacturer Narrative

H10: manufacturing review: a lot history record review could not be completed as the lot number was not provided.Investigation summary: one mri low-profile port with groshong catheter in two segments and cathlock was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.A photo and a radiograph image were provided and reviewed.The investigation is confirmed for complete catheter break and catheter embolism, as the groshong catheter was returned in two segments.A complete circumferential break was identified near the 15 cm depth marker or approximately 10.4 cm from the distal end of the cathlock.Two short longitudinally aligned splits were identified extending from either side of the complete break, and one short longitudinally aligned split was observed just proximal to the distal end of the proximal catheter fragment.The cross-sectional surfaces of both break ends had regions of granularity with sharp edges and smooth regions with rounded edges.The lumen shape at both break ends appeared to have a flattened elliptical shape.Mushrooming of the catheter was observed at the port-catheter connection on the proximal catheter fragment.These observations are consistent with fracture, material separation, naturally worn and deformation due to compressive stress issues.Per the medical image review, there is embolized catheter tubing overlying the heart from the break at the internal jugular vein insertion site.This is consistent with a device migration issue.The definitive root cause could not be determined based upon available information.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the ifu or other labeling is unknown.However, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the ifu instructs on port implantation, catheter insertion, tunneling the catheter and connecting the catheter to the port.Therefore, the product labeling will be considered adequate.H10: g4, h6(device code - 2988, 2889, 1395/4003) h11: d10, h3, h6(method, results, conclusion) h11:section a through f - the information provided by bd represents all of 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 two years and one month post port placement in the left chest wall via left internal jugular vein, a chest radiography allegedly demonstrated a catheter rupture.Reportedly, the catheter remained in the atrium and ventricle.It was further reported that the port and catheter were removed under digital subtraction angiography (dsa).The patient remained in the hospital for one week.There were no further reported complications.

• Brand Name: GROSHONG PORT S/L CHINA ONLY
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9516528
• MDR Text Key: 172597948
• Report Number: 3006260740-2019-04006
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111280
• UDI-Public: (01)00801741111280
• Combination Product (y/n): N
• PMA/PMN Number: K081311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 55