MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER

Model Number	114-009
Medical Device Problem Codes	Crack (1135); Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth, age, sex and weight unavailable from facility.Device evaluation: the device was returned and evaluated on 17 october 2019 by a cross functional engineering team.A wrinkle to the outer jacket was confirmed just below the distal band at the distal tip of the device.A breach to the device's outer jacket and broken fibers were confirmed at the wrinkled area.The team determined the damage came from an external source because the outer jacket was damaged and only the outer layer of fibers had been broken.There was no damage on the inside of the catheter.The team confirmed the reported complaint, but was unable to determine how the damage occurred.
Event or Problem Description
A coronary vascular intervention procedure commenced to treat an in stent restenosis (isr) within the patient's circumflex artery.The team reported that when they attempted to load the elca laser sheath onto the wire, they noticed that there was damage near the tip of the elca laser catheter.The elca device was removed, and another elca device was used to successfully complete the case.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

• Brand Name: SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER
• Common Device Name: ELCA
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9287495
• Report Number: 1721279-2019-00192
• Device Sequence Number: 129177
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: (01)00813132025441(17)210801(10)FH119G25A
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019
• Report Date (Section F): 01/01/2005

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 Expiration Date: 08/01/2021
• Device Model Number: 114-009
• Device Catalogue Number: 114-009
• Device Lot Number: FH119G25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005