MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ELCA CORONARY LASER ATHERECTOMY CATHETER; DEVICE, ANGIOPLASTY, LASER, CORONARY

Model Number	110-004
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A coronary atherectomy procedure commenced to treat a slightly calcified distal left anterior descending (lad) artery.A spectranetics elca laser atherectomy catheter was placed over a terumo 0.014 runthrough guidewire, and inserted through a cordis 6f guide catheter.During advancement, resistance was encountered inside of an existing stent; however, the elca progressed until it reached the lad located within another stent distally, and activated.Resistance was encountered again; therefore, fluency and rate of the laser catheter was increased, without success.The decision was then made to abandon the procedure, and when attempting to remove the elca, it would not retreat back into the guide catheter, even after some trouble shooting.The entire system was removed from the body, when the patient experienced arm pain; and was administered standard medication to relieve the pain.(per philips clinical assessment, the arm pain is not related to the elca or the guide wire, and was likely related to arterial spasm around the guide catheter.) outside of the patient, a piece of plastic was observed extending out from the guidewire exit port, along with a damaged guidewire that was removed in the reverse direction from normal protocol.The patient survived the procedure.This report is being submitted due to removal as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
A2: patient age and date of birth: not available from facility.A3b: patient gender: not available from facility.A4: patient weight: not available from facility.B6: relevant tests/laboratory data: not available from facility.D4: device serial number: not available from facility.H3/h6: the elca device was not returned for evaluation, thus no returned product investigation was performed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
H3) the elca was returned without the non-philips guidewire.Visual inspection found the inner lumen pulled out of the rx port, and the outer jacket was torn.Exposed fibers were visible in the rx port area, and a breach to the outer jacket was confirmed.In the initial mdr, it stated that a piece of plastic was extending out from the guide wire exit port, which device evaluation identified that it was the inner lumen material.H6) based on the device evaluation, a probable cause was a use-related failure.Historically, the manufacturer has seen this failure during manipulation of the device, when the guide wire is pulled laterally away from the port, resulting in the damage observed.However, the cause of the elca becoming stuck on the guidewire could not be established since the guidewire was not returned.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: ELCA CORONARY LASER ATHERECTOMY CATHETER
• Common Device Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 21931154
• Report Number: 3007284006-2025-00086
• Device Sequence Number: 15631966
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)270103(10)0303372753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: 0303372753
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS: 6F GUIDE CATHETER.; PHILIPS LASER SYSTEM.; TERUMO: 0.014 RUNTHROUGH GUIDE WIRE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American