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

Model Number	110-004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A coronary atherectomy procedure commenced to treat a moderately calcified lesion in the patient's mid left anterior descending (lad) coronary artery.The physician used a spectranetics elca coronary atherectomy catheter to treat the patient.During the procedure, the device was removed and it was observed that an internal piece of the device was sticking out of the proximal portion of the rapid exchange port where the guide wire is inserted.A new elca device of the same model was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
Patient's date of birth unk.Relevant tests/laboratory data unk.The device has not returned to the manufacturer, thus no investigation could be completed.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer 26 apr 2022.G3): device evaluation and investigation were completed 28 apr 2022.H3): the device was returned and evaluated by a cross functional team.The device''s inner lumen was pulled away from the guide wire port, causing bunching up and ripping of the device''s outer jacket.With the outer jacket damaged and the inner lumen pulled away from the guide wire port, this caused the device''s fibers to be exposed.Twists were seen in the outer jacket extending from the guide wire port to the distal tip; no breaches were detected in the twisted areas.H6): historically, the manufacturer has seen this damage during removal of the device, when the guide wire is pulled perpendicularly away from the guide wire port, resulting in the inner lumen pulling away from the guide wire port.This creates outer jacket damage and exposed fibers.Based on the device evaluation and investigation (outer jacket ripped and twisted, inner lumen pulled away from guide wire port, exposed fibers) this failure has been determined to be use related.

• 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: 14197298
• Report Number: 1721279-2022-00072
• Device Sequence Number: 11876701
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)231027(10)FG021K06A
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910001 S114
• 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): 04/05/2022

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: 10/27/2023
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG021K06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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: ABBOTT FIELDER 0.014 GUIDE WIRE; MEDTRONIC 6F GUIDE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White