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

Model Number	110-004
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient"s date of birth, age unk.Patient''s gender unk.Patient''s weight unk.Patient''s ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Because the device was not returned for evaluation, the cause of the reported damage could not be determined.
Event or Problem Description
A coronary atherectomy procedure commenced to treat a severely calcified lesion a distal saphenous vein graft (svg) to the left anterior descending (lad) coronary artery.The physician chose to use a spectranetics elca coronary atherectomy catheter to treat the patient.When the elca catheter was turned on inside the patient, the device would not work.The physician removed the catheter and noticed the distal part of the catheter had a hole in it, with a thread of something stuck out of the hole.In the photos provided to the manufacturer, material deformation was apparent in a portion of the device''s working length.The physician aborted the procedure with no reported patient harm.Based on the event description and photos provided, this event is being reported for unintended radiation exposure, potential for harm.

• 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: 13690737
• Report Number: 1721279-2022-00039
• Device Sequence Number: 1906324
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)230611(10)FG021F02A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG021F02A
• 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: 02/08/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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: 6F GUIDE CATHETER MANUFACTURER UNK; 6F INTRODUCER SHEATH MANUFACTURER UNK; RUN THROUGH GUIDE WIRE SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown