MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/GROS 7.0F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0603870
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Embolism (1829); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that approximately four months post port placement via the right internal jugular vein, the patient allegedly heard the device crack while sleeping.Reportedly, the healthcare provider examined via x-ray image and approved the catheter for chemotherapy use, however, during chemotherapy the patient alleged pain so the infusion was interrupted.Furthermore, a contrast image examination demonstrated an alleged catheter break.Reportedly, the catheter migrated to the heart, and the device was removed and replaced.The patient was reported to be stable.
Additional Manufacturer Narrative
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: based on the medical image review of one electronic photo and two videos were provided for review.Based on the results from the image review, the investigation is inconclusive for the alleged catheter break as no objective evidence has been provided to confirm any alleged deficiency with the catheter.However, based on the sample evaluation, one m.R.I.Lp implantable port with 7 fr s/l groshong catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.The investigation is confirmed for subcutaneous break with catheter embolism, as the distal end of the catheter attached to the port was missing.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Most likely, this failure might have been caused from the stylet portion left inside the catheter.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 months post port placement via the right internal jugular vein, the patient allegedly heard the device crack while sleeping.Reportedly, the healthcare provider examined via x-ray image and approved the catheter for chemotherapy use, however, during chemotherapy the patient alleged pain so the infusion was interrupted.Furthermore, a contrast image examination demonstrated an alleged catheter break.Reportedly, the catheter migrated to the heart, and the device was removed and replaced.The patient was reported to be stable.

• Brand Name: MRI L/P PORT W/GROS 7.0F
• 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: 8339387
• Report Number: 3006260740-2019-00250
• Device Sequence Number: 14010572
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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 Expiration Date: 10/31/2022
• Device Model Number: 0603870
• Device Catalogue Number: 0603870
• Device Lot Number: REBX1612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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: Required Intervention