MAUDE Adverse Event Report: STERILMED, INC. CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	BIOBD710FJ282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by sterilmed, inc, or its employees that the report constitutes an admission that the product, sterilmed, inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number:(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a catheter ez steer bi-directional cs defectable curve type: f-j 12 pin auto id.The patient suffered a cardiac tamponade requiring a pericardiocentesis.It was reported that the procedure was completely stopped due to the patient having a pericardial effusion.They stated that they crossed into the left atrium and mapped.The physician noticed that there was an effusion present in an unknown location.The procedure was stopped and a pericardiocentesis was performed.The thermocool® smart touch® sf bi-directional navigation catheter, octaray, galaxy, 48p, 3-3-3-3-3, d-curve, reprocessed soundstar eco catheter (lot #2189176), reprocessed cs catheter (premier plural), and a vizigo sheath were removed from the patient's body.The patient was not stable at that time and they did not know the patient's prognosis at that time.The physician had called ct surgery for a consult.They also stated that the physician did not know what caused the effusion.Additional information was received stating no ablation was carried out in the procedure and the event occurred during the mapping phase.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The investigation was completed on (b)(6) 2023.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine 92618 ; 3035526892
• MDR Report Key: 16724224
• Report Number: 2134070-2023-00013
• Device Sequence Number: 7967200
• Product Code: NLH
• UDI-Device Identifier: 10888551005944
• UDI-Public: 10888551005944
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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 Model Number: BIOBD710FJ282CT
• Device Catalogue Number: BIOBD710FJ282CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.5F SHEATH WITH CURVE VIZ MDC; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; STERILMED SOUNDSTAR ECO CATHETER; THMCL SMTCH SF BID, TC, F-J
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown