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

Model Number	110-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Iatrogenic Source (2498); Cardiac Perforation (2513)
Date of Event	04/27/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
On 29 june 2018, mw5077936 was received via mail from fda.An mdr (1721279-2018-00063) was submitted 21 may 2018 for this event.However, the report sent from the facility contained additional information: device model and lot numbers now available, including device expiration date and udi.Additional concomitant elca device reported to be used during the procedure.Initial reporter also reported to fda.This information was previously unknown.Device manufacture date now available.

• Brand Name: SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER
• Common Device Name: ELCA
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO
• MDR Report Key: 7531881
• Report Number: 1721279-2018-00063
• Device Sequence Number: 13866055
• Product Code: LPC
• UDI-Device Identifier: 00813132025472
• UDI-Public: 00813132025472
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018
• 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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/26/2020
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG018A24A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/05/2018
• 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: Death
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005