MAUDE Adverse Event Report: STERILMED, INC. EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	BIOD6-DR-005-RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with an ep diagnostic catheter quadripolar d-type/blue and the blue coating on the tip of catheter was sheared off.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with an ep diagnostic catheter quadripolar d-type/blue and the blue coating on the tip of catheter was sheared off.The returned product was visually examined under a magnification scope.While there were observed contaminants on the handle and shaft of the device, upon receipt, the device appears free from stains or discoloration.There are no observed cuts, gouges, scrapes, dents, defects, physical abnormalities and other damage.The device's shaft does not appear kinked or deformed due to twisting or bending.And all joints and electrodes appear intact with no visual separation or damage.The device appears whole and intact.There is no indication of any part of the device or tip being sheared off.The reported issue is not confirmed.The device history record for lot 2133664 shows that the device passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted and there were no identified nonconformances.Manufacturer's ref.No: (b)(4).

• Brand Name: EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 10532164
• Report Number: 2134070-2020-00007
• Device Sequence Number: 16907985
• Product Code: NLH
• UDI-Device Identifier: 10888551006408
• UDI-Public: 10888551006408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 04/27/2021
• Device Model Number: BIOD6-DR-005-RT
• Device Catalogue Number: BIOD6-DR-005-RT
• Device Lot Number: 2133664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1