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

Model Number	114-009
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth and age unavailable.Patient's weight unavailable.Device evaluation: both the elca device and marker band were returned to the manufacturer and were evaluated on 30 january 2020.Upon evaluation, the proximal and distal end of the band shows no damage.The external surface of the band shows scuff marks.In the spectranetics instructions for use (ifu), 4.Indications for use, treating underexpanded stents is not listed as an indication for use.This event's indication for use is considered to be off-label and unapproved.
Event or Problem Description
A coronary vascular intervention procedure commenced.The procedure indication was reported to treat underexpanded stents present in the mid left anterior descending (lad) artery.The physician used a spectranetics elca device and successfully completed ten passes with the device in this area.When the physician pulled the elca catheter out through the stents, the radiopaque marker band (normally present at the device's' distal tip) detached in the patient's artery.A sapphire balloon was used to retrieve the marker band successfully.The patient survived the procedure with no reported patient injury.
Additional Manufacturer Narrative
In h11 of the initial mdr, under device evaluation, the last sentence requires correction.In a review of this mdr on 08 jan 2021, it was discovered that this sentence stated the use of the device was unapproved, which is not correct; the elca device is approved for use in the coronary arteries.This sentence is now corrected to state: the use of the elca device in this event to treat underexpanded stents was not listed on the label.This supplemental mdr is being submitted to capture this correction.

• 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: 9672537
• Report Number: 1721279-2020-00023
• Device Sequence Number: 10851131
• Product Code: LPC
• UDI-Device Identifier: 00813132025441
• UDI-Public: (01)00813132025441(17)201112(10)FH118L09A
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: 114-009
• Device Catalogue Number: 114-009
• Device Lot Number: FH118L09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F GUIDE WIRE MANUFACTURER UNKNOWN; 7F INTRODUCER SHEATH MANUFACTURER UNKNOWN; SAPPHIRE BALLOON MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005