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

Model Number	110-004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Relevant tests/laboratory data unk.The device was not returned, thus investigation could not be completed.
Event or Problem Description
A percutaneous coronary intervention (pci) commenced to treat a chronic total occlusion (cto) of the patient's mid right coronary artery.The physician chose to use a spectranetics 9f elca coronary atherectomy catheter.The physician performed four passes through the lesion, all with a continuous forward motion.The elca device sat, lasing at the cap of the lesion for approximately three seconds for either three or four of the passes.After treatment, the elca device was removed with ease.Approximately fifteen minutes later, the scrub tech noticed that the radiopaque marker band was not seen at the device's distal tip.Fluoroscopic images were taken, and the physician stated he was sure the marker band was out of the body.The polymer coated wire that was used concomitantly with the elca device was removed from the patient as well.The physician used another guide wire to re-cross the lesion, and the procedure was completed using a rotablator, a balloon and a stent with no reported patient harm.This report captures the elca device in use when the device's marker band detached, requiring intervention.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 15 mar 2022.G3): device evaluation and investigation were completed on 31 mar 2022.H3): the device was returned and evaluated by a cross functional team.Upon the initial observation, the distal marker band was completely covered by a charred substance that was identified as biologics.With the biologics removed, the distal marker band was present in its entirety and in good working condition.However, at the device's distal tip, there was severe epoxy erosion.Historically, the manufacturer has seen this type of damage at the distal tip when lasing is performed to treat a chronic total occlusion (cto) when there is insufficient flush at the distal tip.Flush is needed at the distal tip to absorb the energy emitted by the laser, and a saline infusion protocol is present within the device's ifu.H6): the device evaluation concluded there was inadequate flushing at the distal tip of the device.This has been determined to be a use related failure.

• 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13638866
• Report Number: 1721279-2022-00040
• Device Sequence Number: 2124242
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458(17)230901(10)FG021H23A
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: FG021H23A
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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; ABBOTT PILOT 200 GUIDE WIRE SIZE UNK; BALLOON MANUFACTURER UNK; BOSTON SCIENTIFIC ROTABLATOR; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; STENT MANUFACTURER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White