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

Model Number	110-004
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	04/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3/h6): the device was not returned; therefore, the suspected marker band separation could not be confirmed.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 severely calcified chronic total occlusion (cto) of the patient''s right coronary artery (rca).An elca coronary atherectomy catheter was used to treat the patient.After several attempts at clearing the lesion, the elca was removed from the body.The tip of the catheter was discovered to be damaged, and radiography showed there seemed to be foreign bodies remaining in the crown of the lesion.It could not be confirmed if the foreign bodies were components of the elca.Additional methods to attempt dilation were not sufficient to open the lesion.The original cto was not cleared, the patient''s vital signs remained stable, and no further follow up was performed.The patient survived.This report is being submitted in an abundance of caution, to capture the elca with suspected marker band separation, possibly retained in the patient.
Event or Problem Description
Based on the device evaluation, the distal marker band was present on the elca device.However, visual inspection found a portion of the epoxy and fiber tips missing from the distal tip.This report is being corrected to capture the missing material at the distal tip, potential for harm.
Additional Manufacturer Narrative
D9): device was returned to the manufacturer 05jun2023.G3): the device evaluation and investigation were completed 12jun2023.H3): visual inspection of the elca device found that the distal marker band was present.However, charring and burnt biologics were visualized, and fiber tips, along with a little less than half of the epoxy, were missing.H6): further investigation concluded the physician maintained saline irrigation and flushing technique, and was not lasing in the presence of contrast medium.Therefore, it is suspected that the target lesion (cto) contributed to the difficulty of hydration reaching the treatment site.This may have created excessive laser (thermal) energy, resulting in burnt/charred biologics and missing material at the distal tip.Medical device problem code 2907 no longer applicable; code 1562 remains appropriate.Component code corrected to 3123 (from 943 and 4717); distal marker band was present, but missing material was noted.All other codes listed in the initial mdr remain applicable.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 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: 16956254
• Report Number: 1721279-2023-00076
• Device Sequence Number: 3613676
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)241025(10)FG022K19A
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910001 S118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 10/25/2024
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG022K19A
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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: GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female