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

Model Number	110-004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.Device evaluation: the device was returned and evaluated by a cross functional engineering team on 16 july 2020.Evaluation found the guide wire port was separated from the device's inner lumen.No other damage was observed to the working length of the device.A 0.014 guide wire was threaded through the device's distal tip; the guide wire successfully threaded through the entire length of the inner lumen; however, the guide wire did not exit the guide wire port as intended.With the device's outer jacket dissected, biologics were identified in the inner lumen and the guide wire was seen exiting the device's inner lumen before reaching the guide wire port.The device's inner lumen was perforated and the fuse connecting the port and the inner lumen was separated.The breach to the device's inner lumen was determined to be caused by force exerted onto the guide wire, which caused the perforation and port separation; this is determined to be a use related failure.After the device evaluation, this event is considered reportable due to the potential for exposure to manufacturing materials and laser energy/radiation due to the breach in the device's working length (outer jacket, inner lumen).
Event or Problem Description
A coronary vascular intervention procedure was being performed, with the physician using a spectranetics elca coronary laser atherectomy catheter to treat the patient.It was initially reported to the manufacturer on 12 june 2020 that while prepping the device on the surgical table, the guide wire came out of the device from an opening other than the guide wire port.It was reported the catheter was torn 2 inches from the device''s distal tip.Follow up questions were asked of the philips representative on (b)(6) 2020; per report, the facility saw no exposed or visible fibers from the reported hole, nor did they see light coming from the hole.It was reported that they weren't aware of the device entering the patient''s body, and they also reported observing a hole in the device''s packaging when the guide wire was threaded into the device.The procedure was successfully completed using a second elca device with no reported patient harm.However, when the elca device was returned to the manufacturer and evaluated on (b)(6) 2020, a breach in the device''s construction was identified.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 LASER ATHERECTOMY CATHETER
• Common Device Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10378952
• Report Number: 1721279-2020-00162
• Device Sequence Number: 17038557
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)220212(10)FG020B04A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2020
• 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: 02/02/2022
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG020B04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• 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: 07/16/2020
• Initial Report FDA Received Date: 08/07/2020
• 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