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

Model Number	117-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Cardiac Perforation (2513)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's age and date of birth unavailable.Patient's weight unavailable.
Event or Problem Description
A coronary atherectomy procedure commenced to treat an acute myocardial infarction (ami) at the right coronary artery #2 (rca #2).The physician chose to use a spectranetics elca coronary laser atherectomy catheter to treat the area; however, during use of the elca device, a perforation occurred, confirmed by transesophageal echocardiography (tee).They treated the perforation using a percutaneous transluminal coronary angioplasty (ptca)catheter and an abbott medical graftmaster coronary stent graft system.The intervention was successful and the patient survived the procedure.There was no alleged malfunction of the elca device in use during the procedure.

• 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: 11355289
• Report Number: 1721279-2021-00024
• Device Sequence Number: 4831425
• Product Code: LPC
• UDI-Device Identifier: 00813132025434
• UDI-Public: (01)00813132025434(17)220127(10)FH219M17A
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P910001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: 117-016
• Device Catalogue Number: 117-016
• Device Lot Number: FH219M17A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2021
• 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: Hospitalization; Life Threatening; Required Intervention