MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603880C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products that are cleared in the us.The pro code for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products is identified.As the lot number for the device was provided, a manufacturing review will 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.Medical device expiry date - 09/2021.

Event Description

It was reported approximately one year and seven months post port placement through right jugular vein, allegedly developed thrombosis when viewed under ultrasound.The patient is stable post removal.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products that are cleared in the us.The pro code for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f products is identified in d2.H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was not returned for evaluation.Therefore, the reported thrombosis cannot be confirmed.A 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: b5, d4 expiry date (09/2021), g4.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 six months post port placement through the right internal jugular vein, the patient allegedly developed thrombosis that was identified under ultrasound.It was further reported that the port was successfully removed under local anesthesia after thrombolytic therapy.The patient was reportedly discharged the same day.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F
• 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: 10318596
• MDR Text Key: 200214744
• Report Number: 3006260740-2020-02680
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111167
• UDI-Public: (01)00801741111167
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603880C
• Device Lot Number: RECX1748
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR