MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. POWERWIRE RADIOFREQUENCY GUIDEWIRE KIT; PERCUTANEOUS CATHETER

Model Number	EWK35-250-12-6A-30-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as the baylis device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.The reported patient complication is an inherent risk in this type of procedure.
Event or Problem Description
During a procedure in which the powerwire radiofrequency guidewire kit was used, it was suspected that a tamponade occurred.The physician attempted to cross an occluded superior vena cava (svc) with the powerwire and was successful.Fifteen minutes later, while introducing other wires, sheaths and a balloon into the patient, the patient's status deteriorated and a code was called.The physician believed that a tamponade occurred.Various healthcare professionals were called to assist with the complication.Chest compressions were performed on the patient.The patient regained their pulse and was reported to now be doing fine.There is no evidence to suggest that a baylis medical device caused or contributed to the reported incident.However, as baylis medical device were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: POWERWIRE RADIOFREQUENCY GUIDEWIRE KIT
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• MDR Report Key: 9548583
• Report Number: 9710452-2020-00001
• Device Sequence Number: 2282553
• Product Code: PDU
• UDI-Device Identifier: 00685447001072
• UDI-Public: (01)00685447001072(17)220328(10)EKFA040419
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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: 03/28/2022
• Device Model Number: EWK35-250-12-6A-30-05
• Device Lot Number: EKFA040419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• 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