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

Model Number 025-100

Device Problem No Pacing (3268)

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

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

Unable to confirm user's report at this time.Engineering is trying to schedule meeting with user to better understand the complaint and use conditions.There have been no other complaints similar to this one.Product not returned by customer.

Event Description

Surgeon stated that when he cut the needle from the pacing wire the tip of the wire was left exposed and when it touched tissue the pacing wire "shorts out" and did not pace.

• Brand Name: A&E MEDICAL CORPORATION MYO/WIRE TEMPORARY CARDIAC PACING WIRE
• Type of Device: TEMPORARY PACING WIRE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury rd.; farmingdale NJ 07727
• Manufacturer (Section G): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: bill kilby ; 5206 asbury road; farmingdale, NJ 07727 ; 7329382266
• MDR Report Key: 6063148
• MDR Text Key: 58617838
• Report Number: 2242056-2016-00008
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10841291100324
• UDI-Public: 10841291100324
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 025-100
• Device Catalogue Number: 025-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• 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
• Patient Outcome(s): Required Intervention