MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOME SUBQ PORT, GROSHONG; IMPLANTABLE PORT

Model Number	0602850
Medical Device Problem Codes	Disconnection (1171); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Thrombus (2101); Pericardial Effusion (3271)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that seven years six months post port device implant, the catheter allegedly detached from the hub and migrated to the right heart, which was revealed through imaging, echocardiogram, and trans-esophageal diagnostic tests.It was further reported that the catheter was visualized in the right atrium with an attached density suspected to a portion of the catheter or thrombus.Reportedly, the port body and catheter were removed without complication.The patient was discharged home and reported to be hemodynamically stable.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: one ti dome port with groshong catheter in two segments and one cathlock were returned for evaluation.Visual, microscopic, and functional evaluations were performed.The investigation is confirmed for a complete break in the catheter due to flexural fatigue, as a complete break in the catheter was identified approximately 1.7 cm from the distal end of the cathlock.Both cross-sectional surfaces at the complete break were observed to have a region that appeared to be smooth and polished with rounded edges and a region that appeared to be granular with sharper edges.The catheter lumen at the break appeared to have a flattened elliptical shape.A definitive root cause could not be determined.It is unknown whether patient and/or procedural factors contributed to the event.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.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 or Problem Description
It was reported that seven years six months post port device implant, the catheter allegedly detached from the hub and migrated to the right heart, which was revealed through imaging, echocardiogram, and trans-esophageal diagnostic tests.It was further reported that the catheter was visualized in the right atrium with an attached density suspected to a portion of the catheter or thrombus.Reportedly, the port body and catheter were removed without complication.The patient was discharged home and reported to be hemodynamically stable.

• Brand Name: DOME SUBQ PORT, GROSHONG
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9880959
• Report Number: 3006260740-2020-01055
• Device Sequence Number: 2877891
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K880571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 0602850
• Device Catalogue Number: 0602850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XARELTO; XARELTO
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 57