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	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3) patient gender - not available from facility.A4) patient weight - not available from facility.A5/a6) patient ethnicity and race - not available from facility.B6) relevant tests/laboratory data - not available from facility.H3) the elca was returned in two pieces with the distal section intact to the concomitant devices (non-philips: guidewire, introducer sheath, guide catheter).The distal section includes the introducer sheath, working length, and guidewire; measuring 134.5 cm.The guidewire extended approximately 6.7 cm from the distal end of the working length and 164.6 cm proximally from the rx port.The introducer sheath and guide catheter were removed from the elca, with heavy biologics present.Visual inspection found the guidewire folded over itself at the rx port, and the rx port was visibly pulled back, which could lead to the resistance reported.The remaining portion that was in the introducer sheath was in good working condition, with a bend in the introducer sheath that spans 3 cm from the distal tip.Additionally, the outer jacket material was loose and wrinkled, 0.8 cm from the distal tip spanning to 1.2 cm.The proximal section includes the coupler and tail tube; measuring 199.5 cm from the proximal end of the strain relief.The coupler measured 8.8 cm from the proximal end of the coupler to the distal end of the strain relief.At the separation, visual inspection found a stretched outer jacket, exposed fibers, and a broken mandrel that appeared to have a sharp edge.There was no apparent burning on the outer jacket or fibers.Per the complaint details, the device was cut, which could have resulted in the appearance/condition of the mandrel.The overall total length combined is 334 cm, which is within the measurement spec of 338.2 cm.H6) based on the device evaluation and investigation, the probable cause of the elca becoming stuck was use-related.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.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.
Event or Problem Description
A coronary atherectomy procedure commenced to treat a moderately calcified lesion in the distal right coronary artery (rca).A spectranetics elca laser atherectomy catheter, along with a non-philips guidewire and guide catheter were being used to treat the patient.During pullback, it was noted that the elca was stuck in the guide catheter.Therefore, the physician cut the elca and guidewire, and removed everything together, including the guide catheter, keeping the distal portion of the guidewire in place.Treatment was completed using a balloon, with no reported patient harm.This report is being submitted due to entrapment, requiring intervention.

• 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: 23583296
• Report Number: 3007284006-2025-00248
• Device Sequence Number: 9641311
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)270813(10)0303551082
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: 0303551082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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: ASAHI PROWATER 0.014 GUIDEWIRE.; CORDIS 6F GUIDE CATHETER.; PHILIPS LASER SYSTEM.
• Patient Age: 71 YR
• Patient Sex: Male