MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. PROTRACK PIGTAIL WIRE; WIRE, GUIDE, CATHETER

Lot Number	0008485286
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It has been reported that a protrack pigtail wire was selected for use.While in procedure, the provider removed the protrack pigtail wire, and upon inspection the wire had come unraveled.No remnants of the protrack pigtail wire was confirmed by x-ray.No patient complications reported.The device is available to be returned for analysis.Medwatch report: mw5154442.
Additional Manufacturer Narrative
Correction to the initial mdr: the field h10 (related report number (1)) was updated.Thus, this supplemental report is being filed.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It has been reported that a protrack pigtail wire was selected for use.While in procedure, the provider removed the protrack pigtail wire, and upon inspection the wire had come unraveled.No remnants of the protrack pigtail wire was confirmed by x-ray.No patient complications reported.The device is available to be returned for analysis.Medwatch report : mw5154442.

• Brand Name: PROTRACK PIGTAIL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19498019
• Report Number: 2124215-2024-35127
• Device Sequence Number: 7926040
• Product Code: DQX
• UDI-Device Identifier: 00685447001003
• UDI-Public: 00685447001003
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K111288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: Health Professional
• Device Expiration Date: 07/31/2026
• Device Lot Number: 0008485286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/27/2024
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female