MAUDE Adverse Event Report: A&E MEDICAL CORPORATION MYO/WIRE ULTRA-FLEX TEMPORARY PACING WIRES; TEMPORARY CARDIAC PACING WIRE

Model Number	024-100
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer did not return device for evaluation.No other reported issues with this product at the user site and no other reported issues of the needles being difficult to break off at the score mark.No other issues have been reported for this product lot from other customers.The device history record review did not indicate any manufacturing related problems.At this point in time, this event appears to be isolated and root cause is undetermined.
Event or Problem Description
The user had difficulty breaking the needle of the pacing wire at the score mark.It eventually broke with a lot of pressure, and the surgeon's finger got poked by the wire.

• Brand Name: MYO/WIRE ULTRA-FLEX TEMPORARY PACING WIRES
• Common Device Name: TEMPORARY CARDIAC PACING WIRE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 10676718
• Report Number: 2242056-2020-00006
• Device Sequence Number: 3524615
• Product Code: LDF
• UDI-Device Identifier: 20841291100147
• UDI-Public: (01)20841291100147(10)01390(17)250501
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K803086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 05/01/2025
• Device Model Number: 024-100
• Device Catalogue Number: 024-100
• Device Lot Number: 01390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 115