MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC PROTRACK PIGTAIL WIRE; WIRE, GUIDE, CATHETER

Model Number	PTW-25-230
Medical Device Problem Codes	Difficult to Insert (1316); Nonstandard Device (1420); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that during a farapulse procedure indicated for atrial flutter (af), a protrack pigtail wire was selected for use.The physician could not get the wire to move in the cheater/insertion tool directly out of the package.The issue was noted while advancing the insertion tool over the pigtail.While using hemostats to dislodge, the stuck wire splashed himself in the eye with blood.The blood splash was from his hands, that came from the groin initially.The physician was able to get it unstuck and utilize the wire.The procedure was completed with the same device.No patient complications occurred.The device was not inserted into a metal tool.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the pkg-transseptal guidewire 230cm returned reloaded into dispenser assembly.During the dimensional verification conducted, device's diameter was within specifications.Additionally, no resistance was noted when advancing the wire from the dispenser assembly thought the insertion tool.Also, it was noted a distal end bend damage, creating excessive lift.The reported allegation cannot be confirmed.The device was returned but there is insufficient information as the device performed as expected.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Correction to the initial mdr in block(s) mfr site facility name, mfr site address 1, mfr site city, mfr site zip/post code, mfr site country (g1), in section g - all manufacturers.
Event or Problem Description
It was reported that during a farapulse procedure indicated for atrial flutter (af), a protrack pigtail wire was selected for use.The physician could not get the wire to move in the cheater/insertion tool directly out of the package.The issue was noted while advancing the insertion tool over the pigtail.While using hemostats to dislodge, the stuck wire splashed himself in the eye with blood.The blood splash was from his hands, that came from the groin initially.The physician was able to get it unstuck and utilize the wire.The procedure was completed with the same device.No patient complications occurred.The device was not inserted into a metal tool.The device is expected to be returned for analysis.

• Brand Name: PROTRACK PIGTAIL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23090184
• Report Number: 2124215-2025-65830
• Device Sequence Number: 16081155
• Product Code: DQX
• UDI-Device Identifier: 00685447001010
• UDI-Public: (01)00685447001010
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 Model Number: PTW-25-230
• Device Catalogue Number: PTW-25-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown