MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491851
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/27/2025
Type of Reportable Event	Serious Injury
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, "emerging use" 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.
Event or Problem Description
Related product model#: 42415, related product serial#: no value found, related product upn#: m001491851, related product batch/lot: 0009622743, related product family: starter, material number: m001491851, 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: procedure cancelled/rescheduled, non bsc product used patient outcome: f23: unexpected medical intervention, f2303: medication required, f08: hospitalization or prolonged hospitalization, f1001: absence of treatment, 104: cancelled/rescheduled - post sedation/sedation unknown event description: ecn event description: physician used an agilis steerable sheath instead of the faradrive.Physician noted the agilis was difficult to steer.Mapping specialist from abbott noted she was not able to visualize the wire.All connections were checked.Physician noted drop in bp.Pericardial effusion noted and drained.Procedure was not completed.Total of 26 ablations.(left superior 4 basket, 4 flower, left inferior 8 flower, right superior 6 basket, 6 flower, right inferior no ablations).What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? staff attempted to reconnect wires for alligator clips to visualize the wire what is the next course of action? pe was treated by staff and drained.Patient present at time of event? yes, patient complications: pericardial effusion, overstimulation in the physician's opinion, did the device or procedure cause or contribute to the patient complication? yes, please describe the way in which the device or procedure caused or contributed to the patient complication? physician stated trouble with the agilis sheath felt stiff and difficult to steer.Mapper from ensite (abbott) also noted she was not able to visualize the wire during procedure.Connections were checked and still no visual.Proceeded and pe resulted.Medical or surgical interventions: pe drained/inserted.Albumin started.Patient discharged from hospital? no patient outcome: the issue is ongoing procedure number: pn-2800669 reason for unsuccessful procedure: implanter chose to use the agilis sheath instead of the faradrive.Was having difficult time steering during procedure.Pe created and drained with kit.Implanter verbally stated he was having difficulty steering the agilis sheath.26 pulses completed.Event date: 2025-8-27.As reported device codes: 2099: no known device problem.As reported patient codes: 9221: pericardial effusion, 9139: hypotension.

• 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: 23552837
• Report Number: 9681477-2025-00132
• Device Sequence Number: 21153101
• Product Code: DQX
• UDI-Device Identifier: 08714729326908
• UDI-Public: (01)08714729326908(17)280522(10)9622743
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2025
• Device Model Number: M001491851
• Device Lot Number: 9622743
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown