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

Model Number 025-201

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

There has only been one prior complaint in the last 2 years from a different user for difficulty with breaking the keith needle on the ultra-flex pacing wires.This results in a complaint rate of (b)(4)% for this problem in the past 2 years (2 complaints for (b)(4) ultra-flex pacing wires sold).A combined total of (b)(4) units of the 2 reported lots have been sold to over 70 different customers, primarily in the us and some international countries.Besides the user pertaining to this complaint, no other users have reported problems with breaking the keith needles from the these lots to date.The incoming inspections of the needles for the reported lots were reviewed and did not indicate any issues; the functional test performed during inspection for groove snap-off met the 5 lb maximum requirement.Production has not reported any in-process issues or seen any changes with the needles that would indicate a problem.Further investigation into this complaint is in process as we try to obtain additional information from the customer.

Event Description

Distributor reported that a surgeon at (b)(6) hospital has had difficulty breaking the keith needle of the pacing wire at the score mark for the past 2 months.In one instance, he"tore his thumb.".

Event Description

Distributor reported that a surgeon at alleghany general hospital has had difficulty breaking the keith needle of the pacing wire at the score mark for the past 2 months.In one instance, he"tore his thumb.".

Manufacturer Narrative

While the complaint units were not available for evaluation, a&e has completed a full investigation of this complaint.The initial communication with the complainant reported 2 lots (01567 and 01834).During the investigation, a third lot (00908) was also identified.Since no units were available from the field, 10 units from lot 01834 that were in finished goods inventory were tested and were found to have an out of specification groove depth (score mark on the needle); this groove depth has a direct impact on the force required to break the needle.While the groove depth was found to be undersized, the parts still met the functional test requirement for groove snap-off force.It can be concluded that variability in the groove depth may result in variability in the force required to break the needle.This may cause the user to apply excessive force to break the needle, thereby causing puncturing or scratching of the fingertip.In order to further investigate the scope of this non-conformance, an npr was issued for all needles currently in production.All keith needles in production were 100% sorted via visual inspection utilizing a magnifying lamp to inspect for an undersized groove depth compared to a known good groove depth.All identified nonconforming parts were removed from production and returned to the supplier.Additionally, skip lot testing was stopped and increased sampling of incoming needle lots was implemented.A supplier corrective action was issued to the keith needle supplier.The supplier determined the root cause to be the grinding wheel wear being undetected during production.As a corrective action, the supplier has implemented in-process checks of groove dimension during the process and prior to sending to the next operation; these checks will be recorded on a production card.Additionally, they will begin to track the life of the grinding wheel to identify the timeline for when it needs to be changed and they are working with their supplier to identify any opportunities to improve the quality of the grinding wheels.A&e will continue to maintain increased receiving inspection to verify effectiveness of these corrective actions.A&e has also improved the measurement methodology for incoming inspection of the keith needles by utilizing a 0 - 1" point micrometer to measure the groove diameter.The point micrometer will have spc data output to facilitate direct measurement to an excel spreadsheet.In the past 5 years, there has only been 1 other complaint related to difficulty breaking the keith needle, which was reported approximately 3 months prior to this one, and there have been no others reported since this complaint.Additionally, the user facility of the complainant continues to use this product.Based on the quantity of ultra-flex boxes sold in the past 2 years from the date this complaint was reported (18dec2018 to 18dec2020), and the 2 reported complaints, the complaint rate is 0.005%.However, given that each box contains 24 wires each, the actual occurrence rate for this issue is 0.0002%.While there is the possibility that product in the field has variability in groove depth, it has obviously not been a significant issue for the majority of users based on the extremely low complaint rate.Due to the fact that needle sticks are often always reportable by the hospital, the likelihood of a similar event occurring and not being reported to a&e is very low.Given that no additional complaints have been reported, this indicates that the variability in needle break force is being tolerated by the user community without issue.Therefore, having addressed in-process needles and all future needle receipts, a&e believes this issue has been addressed with no further actions required.

• 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
• MDR Report Key: 11171576
• MDR Text Key: 226848782
• Report Number: 2242056-2021-00001
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10841291100362
• UDI-Public: (01)10841291100362(10)01567(17)250601;(01)10841291100362(10)01834(17)250801
• Combination Product (y/n): N
• PMA/PMN Number: K803086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 025-201
• Device Catalogue Number: 025-201
• Device Lot Number: 01567; 01834
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1