MAUDE Adverse Event Report: MEDERRI RF, LLC STRETTA CATHETER SYSTEM; ENDOSCOPIC CATHETER

Model Number	8800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericarditis (4448)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Mederi rf was contacted post procedure from a physician regarding a patient's stretta procedure.The physician performed the procedure successfully and indicated there were no complications with performance of the product during the procedure.The patient contacted the physician regarding an adverse event the patient believes may have been in relation to the procedure.
Event or Problem Description
Mederi rf was contacted post procedure from a physician regarding a patient's stretta procedure.The physician performed the procedure successfully and indicated there were no complications with performance of the product during the procedure.The patient contacted the physician regarding an adverse event the patient believes may have been in relation to the procedure.

• Brand Name: STRETTA CATHETER SYSTEM
• Common Device Name: ENDOSCOPIC CATHETER
• Manufacturer (Section D): MEDERRI RF, LLC; 11011 brooklet dr, ste 300; houston TX 77099
• Manufacturer (Section G): MEDERI RF, LLC; 11011 brooklet dr, ste 300; houston TX 77099
• Manufacturer Contact: brad krahel ; 11011 brooklet dr, ste 300; houston, TX 77099 ; 8586733700
• MDR Report Key: 13195495
• Report Number: 3014545051-2021-00001
• Device Sequence Number: 13874600
• Product Code: GEI
• UDI-Device Identifier: 00856219002294
• UDI-Public: (01)00856219002294(17)220826(10)249ST-20
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K152317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: 8800
• Device Catalogue Number: 175-5580
• Device Lot Number: 249ST-20
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COVID-19 VACCINATION SHOT ONE WEEK PRIOR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male