MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491211
Medical Device Problem Codes	Difficult to Advance (2920); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Related product model #: 42255, related product serial #: no value found, related product upn #: m001491211, related product batch/lot: 0009895902 , related product family: starter, material number: m001491211, sterile lot number: no value found, sold to account number: no value found, returned product expected: no, bsc product return date: no value found, location description: no value found.Device/procedure outcome: unable to use device - attempted, original device used, procedure completed.Patient outcome: f26: no health consequences or impact.Event description: ecn event description: physician had prior issues with the j-wire that came in the cath pack for watchman (unfortunately, no lot number is available) so they decided that to open a boston scientific starter guidewire (lot # 9895902) and there was resistance when it was in the dilator.Because they had increased resistance, they removed that and opened an amplatz extra stiff guidewire (lot #16808605) and he still had increased resistance and said that it actually felt like a rachet.He was able to advance the wire into the svc, advance the dilator and trusteer, switch out the wire for the pigtail wire that comes in the versacross kit and finish the case as normal.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: we were able to finish the case like normal but 2 j-wires were tried and both had resistance what is the next course of action?: n/a patient present at time of event?: yes patient complications: no patient complications patient outcome: fully recovered procedure number: pn-2895761 event date: 2025-11-14.As reported device codes: 1274: difficult to advance as reported patient codes: 9398: no clinical signs, symptoms or conditions procedure date: (b)(4) 2025 type of procedure: left atrial appendage closure watchman country of event: united states.
Additional Manufacturer Narrative
No device was returned for analysis.A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint is non-verifiable as the product was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "physician preference" and/or "operational context" appears to have impacted on the event as reported.Without the return of the actual device in question for evaluation, lake region medical is unable to determine the exact cause for this incident.Lake region medical has no open preventative action specific to manufacturing this product differently.As indicated in the ifu (instructions for use) warnings section: never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter, or vessel damage.
Additional Manufacturer Narrative
A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A visual and microscopic examination of the returned product was completed, and the following features were observed: - the guidewire is a 3-piece construction, with a coil, core, and ribbon.The coil, core, and ribbon are welded at the proximal end, and the coil and ribbon are welded at the distal end.- the guidewire returned with the j-shape opened out.- fingerpull test was performed on the returned guidewire confirming that the guidewire was intact.No anomalies were observed to indicate a manufacturing issue with the distal weld or proximal weld.- no other damage was noted on the returned guidewire.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "device interaction" and/or "improper handling" and/or "undetermined cause" appears to have impacted on the event as reported.The root cause is undetermined: cause not established.Lake region medical is unable to determine the exact cause for this incident.Lake region medical has no open preventative action specific to manufacturing this product differently.As indicated in the ifu (instructions for use) warnings section: · do not attempt to move the wire without observing the resultant tip response.
Event or Problem Description
Related product model #: 42255.Related product serial #: no value found.Related product upn #: m001491211.Related product batch/lot: 0009895902.Related product family: starter material number: m001491211.Sterile lot number: no value found.Sold to account number: no value found.Returned product expected: no.Bsc product return date: no value found.Location description: no value found.Device/procedure outcome: unable to use device - attempted, original device used, procedure completed.Patient outcome: f26: no health consequences or impact.Event description: ecn event description: physician had prior issues with the j-wire that came in the cath pack for watchman (unfortunately, no lot number is available) so they decided that to open a boston scientific starter guidewire (lot # 9895902) and there was resistance when it was in the dilator.Because they had increased resistance, they removed that and opened an amplatz extra stiff guidewire (lot #16808605) and he still had increased resistance and said that it actually felt like a rachet.He was able to advance the wire into the svc, advance the dilator and trusteer, switch out the wire for the pigtail wire that comes in the versacross kit and finish the case as normal.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? we were able to finish the case like normal but 2 j-wires were tried and both had resistance.What is the next course of action? n/a.Patient present at time of event? yes.Patient complications: no patient complications.Patient outcome: fully recovered.Procedure number: (b)(4).Event date: 2025-11-14.As reported device codes: 1274: difficult to advance.As reported patient codes: 9398: no clinical signs, symptoms or conditions.Procedure date: (b)(6) 2025.Type of procedure: left atrial appendage closure watchman.Country of event: united states.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: STARTER GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, irl Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, irl Y34 K 825; EI Y34 K825
• Manufacturer Contact: katie slattery ; butlersland; new ross; co. wexford, irl Y34 K-825 ; EI Y34 K825
• MDR Report Key: 23743074
• Report Number: 9681477-2025-00142
• Device Sequence Number: 10208840
• Product Code: DQX
• UDI-Device Identifier: 08714729326540
• UDI-Public: (01)08714729326540(17)280720(10)9895902
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: M001491211
• Device Lot Number: 9895902
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown