MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT

Catalog Number UNKNOWN POWER PORT

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

Patient Problem Arrhythmia (1721)

Event Date 08/25/2022

Event Type  Injury  

Event Description

The following adverse events were identified utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bardtm long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the arrhythmia reported during the use of the powerport m.R.I.Implantable port product (unknown product code).Events range in dates from june 17, 2017-july 26, 2021.Potential device-related adverse events were detected using the presence of diagnosis and procedure codes occurring on the date of port-implant or up to the date of a terminal event.To ensure privacy, the data have undergone statistical anonymization to preclude reidentification with high probability.This de-identification process includes all dates and times, which are randomly adjusted.Therefore, any individual procedure, patient or event information is not available.No part or lot numbers are available, and no devices were returned for evaluation at the time of the study.No additional information regarding this event is available.

Manufacturer Narrative

This initial mdr is being submitted post-discussions with fda mdr leadership.The due date for this mdr is (b)(6) 2022.As the lot number for the device was not provided, a review of the device history records could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive.Based upon the available information, the definitive root cause for these events is unknown.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15764593
• MDR Text Key: 303396456
• Report Number: 3006260740-2022-04795
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening