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U.S. Department of Health and Human Services

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

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A&E MEDICAL CORPORATION ULTRA-THIN PACING WIRE (BIPOLAR V) BIPOLAR TEMPORARY CARDIAC PACING WIRE Back to Search Results
Model Number VF608ABB
Device Problems Device Difficult to Setup or Prepare; Human-Device Interface Problem
Event Date 03/13/2019
Event Type  Injury  
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 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.

 
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Brand NameULTRA-THIN PACING WIRE (BIPOLAR V)
Type of DeviceBIPOLAR 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
bill kilby
5206 asbury road
farmingdale , NJ 07727
7329382266
MDR Report Key8501172
Report Number2242056-2019-00002
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVF608ABB
Device Catalogue NumberVF608ABB
Device LOT Number0001U
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/10/2019 Patient Sequence Number: 1
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