MAUDE Adverse Event Report: A&E MEDICAL CORPORATION ULTRA-THIN PACING WIRE (BIPOLAR V); BIPOLAR TEMPORARY CARDIAC PACING WIRE

Model Number	VF608ABB
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has been unresponsive with follow up questions.Initial complaint verbiage describes device usage that does not align with standard practice of ifu guidance.At this current time a&e medical cannot confirm the complaint.A&e medical is continuing attempts to contact the customer to gain additional information to understand the complaint.There are no similar complaints received for this product vf608abb, lot 0001u.It should be noted there is no return of product indicated at this time from the customer.(b)(4).
Event or Problem Description
Complaint received from customer indicates a difficulty with fixation and conductivity which led to an extended surgical time.Anecdotally customer reports other difficulties with same type of device.The complaint eludes to multiple occasions with more than one device for difficulties with fixation, conductivity and removal.
Event or Problem Description
Complaint received from customer indicates a difficulty with fixation and conductivity which led to an extended surgical time.Annecdotally customer reports other difficulties with same type of device.The complaint eludes to multiple occassions with more than one device for difficulties with fixation, conductivity and removal.Mdr 2242056-2019-00002 was initially written and submitted for complaint (b)(4).Subsequent communication with customer has confirmed the complaint was actually use error.The customer has been communicated to in conjunction with the instructions for use enforcing comprehension of the proper use.
Additional Manufacturer Narrative
Customer has been unresponsive with follow up questions.Initial complaint verbiage describes device usage that does not align with standard practice of ifu guidance.At this current time a&e medical cannot confirm the complaint.A&e medical is continuing attempts to contact the customer to gain additional information to understand the complaint.There are no similar complaints received for this product vf608abb, lot 0001u.It should be noted there is no return of product indicated at this time from the customer.This mdr2242056-2019-00002-001 is a follow up to mdr2242056-2019-00002 submitted 4/10/2019.Subsequent communication with the customer has confirmed the root cause for the complaint was use error.There is no product deficiency.The customer has been communicated with to ensure proper use is now understood.The instructions for use were re-iterated with the customer.There continues to be no other complaints for this product.

• Brand Name: ULTRA-THIN PACING WIRE (BIPOLAR V)
• Common Device Name: BIPOLAR TEMPORARY CARDIAC PACING WIRE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 8501172
• Report Number: 2242056-2019-00002
• Device Sequence Number: 2384224
• Product Code: LDF
• UDI-Device Identifier: 08718627411872
• UDI-Public: 08718627411872
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: 08/01/2021
• Device Model Number: VF608ABB
• Device Catalogue Number: VF608ABB
• Device Lot Number: 0001U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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