MAUDE Adverse Event Report: ALTO DEVELOPMENT CORPORATION A&E MEDICAL CORPORATION MYO/WIRE TEMPORARY CARDIAC PACING WIRE; TEMPORARY PACING WIRE

Model Number	025-100
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to confirm user's report at this time.There have been no other complaints similar to this one.It shall be noted customer returned (3) parts of lot 0709a and (3) parts of lot 0710a for evaluation.Product has been inspected product continuity and visual inspection are satisfactory.Unable to identify root cause for customer's experience.
Event or Problem Description
The customer reported subsequent to placement in the operating room (or), pacing wire stopped pacing in the csu post operative unit after a couple of hours.It was reported this occurred on three separate patients in a short span of time.The surgeon involved has utilized the product for many years.Hospital staff was unable to identify reason for reported failure.No further events were reported.Hospital did not save failed units however returned product from the lot of the reported failed wires as well as one additional lot number.

• Brand Name: A&E MEDICAL CORPORATION MYO/WIRE TEMPORARY CARDIAC PACING WIRE
• Common Device Name: TEMPORARY PACING WIRE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury rd.; farmingdale NJ 07727
• MDR Report Key: 7538900
• Report Number: 2242056-2018-00001
• Device Sequence Number: 1318208
• Product Code: LDF
• UDI-Device Identifier: 10841291100324
• UDI-Public: 10841291100324
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K803086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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
• Operator of Device: Physician
• Device Expiration Date: 10/01/2022
• Device Model Number: 025-100
• Device Catalogue Number: 025-100
• Device Lot Number: 0709A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/23/2018
• 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