MAUDE Adverse Event Report: STERILMED, INC. EP DIAGNOSTIC CATHETER VIKING QUADRIPOLAR JOSEPHSON; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	BAR400001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown, however it did occur in 2019.The device has not yet been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed ep diagnostic catheter viking quadripolar josephson catheter and the tyvek cover was not sealed to the plastic tray on inner packaging when the device was removed from the outer box packaging.The device was exchanged, and the procedure was completed.The intent of the procedure was not altered as a result of this event.The device did not contact the patient.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed ep diagnostic catheter viking quadripolar josephson catheter and the tyvek cover was not sealed to the plastic tray on inner packaging when the device was removed from the outer box packaging.The device was returned for investigation.The packaging was examined on its return.While the tyvek pouch displayed steady transference from the tyvek material to the plastic seal as expected, the plastic tray contained within the outer tyvek pouch did not display any transference from the tyvek lid returned with the complaint device.Only a single point on the tray contained any transference from the lid, and that was not adequate enough to form a proper seal.No discrepancies were noted on the device history record during the manufacturing record evaluation.However, an internal action was created as a response to this complaint.Manufacturer's ref.No: (b)(4).

• Brand Name: EP DIAGNOSTIC CATHETER VIKING QUADRIPOLAR JOSEPHSON
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 9496380
• Report Number: 2134070-2019-00151
• Device Sequence Number: 1854114
• Product Code: NLH
• UDI-Device Identifier: 10888551014007
• UDI-Public: 10888551014007
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K012523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2020
• Device Model Number: BAR400001
• Device Catalogue Number: BAR400001
• Device Lot Number: 2106459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1