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

Model Number	PTW-25-230
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a watchman left atrial appendage closure (laac) procedure, a protrack guidewire was selected for use.After transeptal crossing under intracardiac echocardiography (ice) guidance using non-boston scientific mechanical needle and preface sheath.The physician then removed the needle and inserted the protrack wire in order to exchange to watchman sheath.After inserting the wire, the physician didn't feel right and was attempted to remove it.It was noted that the wire appeared to have unraveled and was only attached by a very narrow thread.It appeared under imaging to be across the septum and through the mitral valve.The physician attempted to snare the wire and was able to remove multiple portions but never the whole wire.The remaining portions were still visible in inferior vena cava (ivc), right and left atrium.The patient was sent to surgery to remove the rest of the wire enterally.Later was, the patient was doing well, and it was discharged.The device is now expected to be returned for analysis.The tech who prepped the wire said not viable damage was noted prior to use it.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field: describe event or problem (b5), in section b - adverse event/product prob.Also, correction to the initial mdr in block(s) f10 and h6 (patient codes), in sections f - for use by uf/importer and h - device manufacturers only.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 was reported that during a watchman left atrial appendage closure (laac) procedure, a protrack guidewire was selected for use.After transeptal crossing under intracardiac echocardiography (ice) guidance using non-boston scientific mechanical needle and preface sheath.The physician then removed the needle and inserted the protrack wire in order to exchange to watchman sheath.After inserting the wire, the physician didn't feel right and was attempted to remove it.It was noted that the wire appeared to have unraveled and was only attached by a very narrow thread.It appeared under imaging to be across the septum and through the mitral valve.The physician attempted to snare the wire and was able to remove multiple portions but never the whole wire.The remaining portions were still visible in inferior vena cava (ivc), right and left atrium.The patient was sent to surgery to remove the rest of the wire enterally.Later was, the patient was doing well, and it was discharged.The device is now expected to be returned for analysis.The tech who prepped the wire said not viable damage was noted prior to use it.It was further reported that the patient is doing well and has been discharged.Retrieval of the wire was attempted in the ep lab by implanting physician.Not all portions of the wire were retrieved so the patient was sent to surgery.Remaining portions of the wire were successfully retrieved during surgery.Physician believes that the wire went through the mitral valve and somehow got stuck on a cordae.Per physician, the patient did not have any additional symptoms or adverse events other than the required surgery.
Additional Manufacturer Narrative
The device has been received for analysis.The investigation of the device determined that it was not possible to measure the coil dimensions.A gage bushing passed over the length of the device up to the proximal aspect of the kink damage.The device also presented a ductile tensile overload fracture of the coil and the core wire at an unknown distance from the distal tip along with extensive stretched coil damage.Next, the device also presented kink damage from the distal aspect of the formed curve.An undetermined length of the distal portion of the device was missing and was not returned.The proximal joint appears to be correct and intact by visual examination and by non-destructive testing.Except where noted, the device appeared visually and dimensionally correct.The investigation concluded that the product met specification at the time of shipment.The reported allegation has not been confirmed based on the testing and analysis of the returned device.Correction to the follow-up 1 mdr in block init rptr also sent rep to fda (e4), in section e - initial reporter.
Event or Problem Description
It was reported that during a watchman left atrial appendage closure (laac) procedure, a protrack guidewire was selected for use.After transeptal crossing under intracardiac echocardiography (ice) guidance using non-boston scientific mechanical needle and preface sheath.The physician then removed the needle and inserted the protrack wire in order to exchange to watchman sheath.After inserting the wire, the physician didn't feel right and was attempted to remove it.It was noted that the wire appeared to have unraveled and was only attached by a very narrow thread.It appeared under imaging to be across the septum and through the mitral valve.The physician attempted to snare the wire and was able to remove multiple portions but never the whole wire.The remaining portions were still visible in inferior vena cava (ivc), right and left atrium.The patient was sent to surgery to remove the rest of the wire enterally.Later was, the patient was doing well, and it was discharged.The device is now expected to be returned for analysis.The tech who prepped the wire said not viable damage was noted prior to use it.It was further reported that the patient is doing well and has been discharged.Retrieval of the wire was attempted in the ep lab by implanting physician.Not all portions of the wire were retrieved so the patient was sent to surgery.Remaining portions of the wire were successfully retrieved during surgery.Physician believes that the wire went through the mitral valve and somehow got stuck on a cordae.Per physician, the patient did not have any additional symptoms or adverse events other than the required surgery.

• 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): LAKE REGION MEDICAL INC; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21836671
• Report Number: 2124215-2025-23320
• Device Sequence Number: 12913482
• Product Code: DQX
• UDI-Device Identifier: 00685447001010
• UDI-Public: (01)00685447001010(17)271230(10)9481053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PTW-25-230
• Device Catalogue Number: PTW-25-230
• Device Lot Number: 0009481053
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 08/19/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 06/12/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female