MAUDE Adverse Event Report: BARD ACCESS SYSTEMS L/P TI CHRFX ATT 6FR MI; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0655510
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	Occlusion (1984); Injury (2348)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.
Event or Problem Description
It was reported that approximately four years post port placement via left internal jugular vein in the right chest the catheter was allegedly occluded.Reportedly, during the port removal procedure it was identified the catheter allegedly adhered to the tissue from the left innominate vein to the superior vena cava.The port hub was able to be removed, but the catheter removal was unsuccessful.It was further reported, approximately one year post port hub removal the catheter eroded through the skin and a thoracotomy was performed to remove the catheter.The patient remains in the hospital recovering from the surgical procedure.
Additional 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: a sample evaluation could not be performed as the samples were not returned.Although the sample was not returned for evaluation, two radiographic images was provided for review.The investigation is inconclusive for catheter blockage, as, per the image review, no break or kink in the device was identified.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: 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 product labeling is adequate.
Event or Problem Description
It was reported that approximately four years post port placement via left internal jugular vein in the right chest the catheter was allegedly occluded.Reportedly, during the port removal procedure it was identified the catheter allegedly adhered to the tissue from the left innominate vein to the superior vena cava.The port hub was able to be removed, but the catheter removal was unsuccessful.It was further reported, approximately one year post port hub removal the catheter eroded through the skin and a thoracotomy was performed to remove the catheter.The patient remains in the hospital recovering from the surgical procedure.

• Brand Name: L/P TI CHRFX ATT 6FR MI
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8865415
• Report Number: 3006260740-2019-02316
• Device Sequence Number: 2070583
• Product Code: LJT
• UDI-Device Identifier: 00801741026317
• UDI-Public: (01)00801741026317
• Combination Product (Y/N): N
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 0655510
• Device Catalogue Number: 0655510
• Device Lot Number: REXG0909
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention