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

Model Number	114-009
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unknown.Relevant tests/laboratory data: unknown.Other relevant history: unknown.Device lot number, expiration date: unknown.The device was not returned, thus no investigation could be completed.Device manufacture date unknown because lot number unknown.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 patient''s right coronary artery (rca).The physician chose a spectranetics elca coronary atherectomy catheter to treat the patient.After lasing was completed, the elca''s distal marker band detached while inside the patient but remained present on the guide wire.No additional intervention was required for retrieval.The case was completed successfully with no reported patient harm.This report captures the elca device in use when its marker band detached, potential for harm.
Additional Manufacturer Narrative
D9): the device was received by the manufacturer on 19 july 2022.G3): the device evaluation and investigation were completed on 21 july 2022.H3): the device was returned and evaluated by a cross functional team.The marker band was confirmed to be detached from the device, but it was not included in the return.The epoxy on the distal tip was in good condition, with no excessive damage observed.The elca's outer jacket was in good condition.No design, use or process related failure was identified.H6): since the marker band was not returned, it cannot be determined why the marker band detached from the distal tip; thus the cause of the damage 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
• MDR Report Key: 14949310
• Report Number: 1721279-2022-00134
• Device Sequence Number: 6231117
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: 00813132025441
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 114-009
• Device Catalogue Number: 114-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 AND SIZE UNK; GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown