MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS ELCA CORONARY 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 Code	Perforation of Vessels (2135)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth: unk.Patient's weight: unk.Relevant tests/laboratory data :unk.Device lot number, expiration date: unk.The device was discarded, thus no investigation could be completed.Device manufacture date: unk because lot number: unk.
Event or Problem Description
A coronary atherectomy procedure commenced to treat a severely fibrous in-stent restenosis (isr) within a vein graft, present in the proximal portion of the patient's left anterior descending coronary artery.The physician chose to use a spectranetics elca coronary laser atherectomy catheter to treat the patient.After the physician had finished lasing, he used a non compliant balloon, inflated the balloon, and the vein graft perforated.The physician put in a covered stent in the vein graft to successfully repair the perforation, and the patient survived the procedure.The physician thinks the perforation could have been a combination of lasing and use of the balloon that caused and/or contributed to the perforation of the vein graft.This report captures the elca device in use within the vein graft when a perforation occurred.There was no alleged malfunction of the elca device in use during the procedure.

• Brand Name: SPECTRANETICS ELCA CORONARY 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: 12712471
• Report Number: 1721279-2021-00204
• Device Sequence Number: 1454475
• Product Code: LPC
• UDI-Device Identifier: 00813132025434
• UDI-Public: 00813132025434
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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 Model Number: 117-016
• Device Catalogue Number: 117-016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/28/2021
• 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 CATHETER MANUFACTURER UNK; 7F INTRODUCER SHEATH MANUFACTURER UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 80 YR