MAUDE Adverse Event Report: STERILMED, INC. EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-F CURVE; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Catalog Number	RD135303
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for analysis.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 ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a wpw (wolff-parkinson-white) ablation procedure using a reprocessed webster cs catheter.The patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.While performing a wpw procedure at the end of the case, it was noticed that the patient's blood pressure was low.The physician discovered and confirmed a pericardial effusion using intracardiac echocardiogram and the ultrasound catheter.The cardiovascular surgeon was called in and the medical intervention provided was a pericardiocentesis and they removed 500 cc's of fluid.The patient was stable.The physician believed that the placement of the reprocessed cs catheter was incorrect and could have caused the effusion.The physician had changed the placement of the catheter after their last ablation burn for a better signal and could have caused the perforation from the placement.Patient was admitted to the intensive care unit overnight.Transseptal puncture was performed.Ablation was performed prior to noting the pericardial effusion.The event occurred post transseptal, post last ablation of left pathway wpw.No cardiovascular surgery was performed.No cardiac perforation was confirmed.
Additional Manufacturer Narrative
It was reported that a patient underwent a wpw (wolff-parkinson-white) ablation procedure using a reprocessed webster cs catheter.The patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.The product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.The lot number was reported as unavailable.As a result, the manufacturing record evaluation review cannot be conducted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4) concomitant products were omitted from the initial report in error.Section d10 was updated.

• Brand Name: EP CATHETER WEBSTER CS UNI-DIRECTIONAL DECAPOLAR WITH AUTO ID CS-F CURVE
• 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, CA 92618 ; 3035526892
• MDR Report Key: 18059557
• Report Number: 2134070-2023-00025
• Device Sequence Number: 7729817
• Product Code: NLH
• UDI-Device Identifier: 10888551039499
• UDI-Public: 10888551039499
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150357
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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 Catalogue Number: RD135303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 11/30/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/13/2023; 12/08/2023
• 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: IMAGING CATHETER; OPTRELL CATHETER; SMARTTOUCH SF CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 78 KG