MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	414-151
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	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unk.Relevant tests/laboratory data unk.Other relevant history unk.The device has been returned to the manufacturer, but has not yet been evaluated.
Event or Problem Description
A philips representative became aware that a procedure in which a spectranetics turbo elite laser atherectomy catheter was in use (indication and location of procedure unk).During use within the patient, the device's distal marker band detached inside the patient.The physician was able to retrieve the marker band using a filter wire, and the procedure was completed with no reported patient harm.Attempts to obtain additional information have not been successful.This report captures the turbo elite device in use when the marker band detached within the patient, requiring intervention.
Additional Manufacturer Narrative
G3): the device was evaluated and investigation completed on (b)(6) 2021.H3): device evaluation: the device was returned and evaluated by a cross functional team.The marker band was returned, detached from the distal tip of the catheter.Looking at the catheter, the distal tip had an epoxy void in the locking feature.No other damage was seen to the catheter.Looking at the distal marker band, the band''s locking feature was present around the entire inner circumference.Measurements of the distal marker band were within specifications.This failure is determined to be production process related.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12627252
• Report Number: 1721279-2021-00190
• Device Sequence Number: 4270925
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)230614(10)FAY21F01A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• 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): 09/15/2021

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: 06/14/2023
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY21F01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown