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

Model Number	114-009
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A coronary atherectomy procedure commenced to treat a slightly calcified soft tissue lesion in the patient's mid right coronary artery (rca).A stent was present in the area, with slight in-stent restenosis (isr) noted.The physician chose a spectranetics elca coronary atherectomy catheter to treat the patient.During the procedure, the distal marker band separated from the device inside the patient.An additional guide wire, along with a teleflex guideliner catheter were advanced, and a balloon was used to successfully retrieve the marker band from the patient.The patient survived the procedure.This event captures the elca in use when the marker band separated, requiring intervention for removal.
Additional Manufacturer Narrative
The evaluation and investigation is ongoing, therefore conclusion not yet available.A supplemental mdr will be submitted upon completion.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
G3/h2): the device evaluation and investigation were completed 17apr2023.H3/h6): the elca device and the detached distal marker band were returned for evaluation.Visual inspection found epoxy damage at the distal tip, and slight chipping to the exposed epoxy at the tip''s edge, with no sharp edges observed.Minimal epoxy was present on the surface of the marker band.A superficial linear groove on the outside of the marker band was noted; however, the marker band appeared to be cylindrical and tapered, per design specifications.The marker band revealed that the small inner diameter (id) measured oversized and the large id was undersized, which did not meet drawing requirements.The measurement of the smaller outer diameter (od) of the epoxy at the device''s distal tip determined it was possible the marker band deformed during use of the device in the procedure.However, the cause of the reported failure could not be established.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: SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER
• Common Device Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16524684
• Report Number: 1721279-2023-00041
• Device Sequence Number: 14057258
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: (01)00813132025441(17)240907(10)FH122H30A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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 Expiration Date: 09/07/2024
• Device Model Number: 114-009
• Device Catalogue Number: 114-009
• Device Lot Number: FH122H30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: MEDTRONIC JR4 GUIDE CATHETER SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO PINNACLE 6F INTRODUCER SHEATH; TERUMO RUN THROUGH 0.014 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female