MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491561
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
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" 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.
Event or Problem Description
Ecn event description: lspv treated with no issues.Physician deployed in flower, retracted the wire from lspv and attempted to wire lipv.Physician stated they felt a lot of resistance on the wire and was hard to advance or pull back into the catheter.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? farawave 31mm removed and used new bsc starter rosen wire, unable to advance fully through the catheter.What is the next course of action? new catheter pulled, no further issues.Patient present at time of event? yes.Patient complications: no patient complications.Procedure number: (b)(6).Device 1: upn m004pf41m401, model number null, lot or serial number (b)(6).Was issue present upon opening package? no.Question: what brand/make of guidewire was used? if a bsc or merit guidewire: please provide the upn & lot#.Answer: bsc starter rosen 1.5mm j - lot unknown.Question: was any tissue seen at the tip of the catheter or guidewire? answer: no.Question: were you able to remove the guidewire as normal? if no: what state was the gw in when the catheter was removed? (ex: within the guidewire, advanced past the tip, etc).Answer: was able to remove initial guidewire from catheter but felt resistance.Guidewire appeared normal.Question: were other catheter malfunctions present? [ex: deployment issues, guidewire lumen detachment or kinking, etc] if yes: please specify.Answer: no.Question: (patient information question not applicable in european region/ canada).Is patient information (patient identifier and age) available? if yes: provide information in the patient section of the form.If no please specify why the information is not available from the facility.Answer: not available.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross, co. wexford Y34 K-825 ; EI Y34 K825
• MDR Report Key: 23035494
• Report Number: 9681477-2025-00094
• Device Sequence Number: 9514340
• Product Code: DQX
• UDI-Device Identifier: 08714729326748
• UDI-Public: (01)08714729326748(17)280524(10)9660364
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/12/2025

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: M001491561
• Device Lot Number: 9660364
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2025
• 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