MAUDE Adverse Event Report: A & E MEDICAL CORPORATION MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES; ELECTRODE, PACEMAKER, TEMPORARY

Model Number V605PBB

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Temporary epicardial pacer wires were placed during cardiac surgery on the day of the surgery.After three days from the surgery, radiology report noted a fractured pacer wire overlying the upper abdomen.It is unknown how pacer wire fractured.The risk of removal was determined to be greater than if it remained.

• Brand Name: MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A & E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 10546365
• MDR Text Key: 207319554
• Report Number: 10546365
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 08718627411537
• UDI-Public: (01)08718627411537
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V605PBB
• Device Catalogue Number: V605PBB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1