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

Model Number VE60WW

Device Problem No Pacing (3268)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

An fda medwatch 3500a report ((b)(4)) was received on 4/6/2020 on behalf of a user-facility indicating that during a routine radiograph the pacing wire was found to be fractured.The device failed and did not work.No patient harm was indicated.No device was returned for investigation.Multiple attempts to contact the reporter (b)(6) and the surgeons at the hospital for further information were unsuccessful (most likely due to covid situation).No specific lot number was reported thus a review of all lot numbers sold to the customer was performed.The following information was found: lot 0010u.Manufactured 2/19/19.Expiration 2/1/22.Udi (b)(4).Lot 0011u.Manufactured 2/25/19.Expiration 2/1/22.Udi (b)(4).Lot 0013u.Manufactured 3/06/19.Expiration 2/1/22.Udi (b)(4).Lot 0033u.Manufactured 7/31/19.Expiration 7/1/22.Udi (b)(4).Lot 0037u.Manufactured 8/20/19.Expiration 8/1/22.Udi (b)(4).Device investigation was not possible since no product was returned.A&e medical was unable to determine the failure mode or replicate the failure.The design history record (dhr) did not indicate an issue with production.The myo/wire® ultra-thin pacing wire is manufactured in accordance to a&e medical procedures.A review of nonconforming product reports (nprs) and complaints found no similar observations or trends associated with this compliant.A&e medical will re-open the complaint and evaluate based upon review should further information be revealed or product be subsequently returned.

Event Description

An fda medwatch 3500a report ((b)(4)) was received on 4/6/2020 2020 on behalf of a user-facility indicating that during a routine radiograph the pacing wire was found to be fractured.The device failed and did not work.No patient harm was indicated.No device was returned.

• Brand Name: MYO/WIRE ULTRA-THIN PACING WIRE
• Type of Device: CARDIAC PACING WIRE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale, nj
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale, nj
• Manufacturer Contact: peter browne ; 5206 asbury road; farmingdale, nj ; 9387337
• MDR Report Key: 10028549
• MDR Text Key: 205175806
• Report Number: 2242056-2020-00001
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2020

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
• Device Operator: Health Professional
• Device Model Number: VE60WW
• Device Catalogue Number: VE60WW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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