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

Model Number	110-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A coronary atherectomy procedure commenced to treat a lesion in the patient's left anterior descending (lad) coronary artery.Multiple guide wires, catheters, and a spectranetics elca coronary atherectomy catheter were used to treat the patient.After the elca made 2 passes at 60/60 fluency/rate and 5 passes at 80/80 fluency/rate, it was removed from the patient.During the procedure, an lad perforation was discovered; the physician stated the elca caused the perforation.Balloons were used within the lad, and a covered stent was deployed to effectively cover the perforation.The patient survived the procedure.This event captures the elca in use when the perforation occurred, requiring intervention.There was no alleged malfunction of the elca device in use during the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was discarded, thus no investigation could be completed.Coronary vessel perforation is a known risk of complication with use of the elca device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
Additional information was received on 15dec2022: indication for procedure was severe in-stent restenosis (isr).Seven attempts were made to cross the lesion with the elca device, but were unsuccessful prior to the lad perforation being discovered.
Additional Manufacturer Narrative
B5/b7): additional information was obtained from the operative notes.G3): philips became aware of additional information on 15dec2022.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15981061
• Report Number: 1721279-2022-00228
• Device Sequence Number: 6922858
• Product Code: LPC
• UDI-Device Identifier: M204110004AA0
• UDI-Public: 00813132020033
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 110-004
• Device Catalogue Number: 110-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI INTECC PROWATER 180 CM GUIDE WIRE; BIOTRONIK PK PAPYRUS STENT; BOSTON SCIENTIFIC EMERGE PTCA DILATATION CATHETER; BOSTON SCIENTIFIC GUIDEZILLA EXTENSION CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TAKERU PTCA BALLOON DILATATION CATHETER; TERUMO 5F TIGER DIAGNOSTIC CATHETER; TERUMO 6F GLIDESHEATH SLENDER INTRODUCER SHEATH; TERUMO 6F IL3.5 HEARTRAIL GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White