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

Model Number 024-100

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/04/2020

Event Type  malfunction  

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 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
• Type of Device: TEMPORARY CARDIAC PACING WIRE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: vashina shukla ; 5206 asbury road; farmingdale, NJ 07727 ; 7329382266
• MDR Report Key: 10676718
• MDR Text Key: 211238429
• Report Number: 2242056-2020-00006
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 20841291100147
• UDI-Public: (01)20841291100147(10)01390(17)250501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 024-100
• Device Catalogue Number: 024-100
• Device Lot Number: 01390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 115