MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	420-050
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the patient''s superficial femoral artery (sfa).Access was obtained in the patient''s right common femoral artery (cfa) and placed a cook ansel outer sheath up and over the aortic bifurcation into the left cfa.A wire was successfully inserted through the mid to distal sfa occlusion and used a spectranetics turbo-power laser atherectomy catheter to treat the patient.When the turbo-power advanced over the aortic bifurcation, resistance was felt and the turbo-power would not advance any further.The turbo power was attempted to be removed over the wire and out of the outer sheath, but it became stuck and the wire kinked.The turbo-power was able to be backed far enough over the wire to cut through the excess sheath that was outside the skin tract and the wire and the turbo-power were removed together.The remaining outer sheath was clamped with hemostats to reduce bleeding, then another 0.035 j wire was advanced through the remaining sheath to save access to the right femoral artery.The cut outer sheath was then removed over the j wire and a new cook ansel sheath was inserted.A new spectranetics turbo elite laser atherectomy catheter was used to successfully complete the procedure with no reported patient harm.However, during device evaluation on 21 apr 2022, it was discovered that a breach to the device''s outer jacket and exposed fibers were present just proximal to the device''s marker band.This report captures the turbo-power which was found to have exposed fibers and a breach to the outer jacket, causing unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
Patient's date of birth unk.Relevant tests/laboratory data unk.The device was returned and evaluated by a cross functional team.The introducer sheath was returned with a portion of the turbo-power's working length contained within it.Using a 0.014 guide wire through the turbo-power''s proximal guide wire lumen which was outside the introducer sheath, slight resistance was felt, due to biologics.Once the guide wire entered the turbo-power''s inner lumen which was within the introducer sheath, severe resistance was encountered and could not pass through the entire length of the inner lumen.Attempts to flush the inner lumen with water were unsuccessful, due to biologics and resistance felt within the introducer sheath.Attempt was made to pull the introducer sheath off the distal portion of the turbo-power''s working length, but was unsuccessful.The introducer sheath was removed in small sections, in order to visualize the turbo-power''s distal tip.After removing 4 cm of the introducer sheath, the turbo-power''s distal tip was visualized, and heavy biologics were present around the distal tip and marker band.When visualizing through the distal tip, the turbo-power''s inner lumen appeared stretched and misshapen due to biologics and excessive force from the guide wire.The turbo-power''s distal marker band was damaged (small dents); unable to determine whether marker band damage occurred prior to or during device evaluation.Just proximal to the marker band, a breach was seen in the turbo-power''s outer jacket, exposing fibers.The turbo-power could be advanced forward through the introducer sheath, but could not be pulled back completely.Clamp marks were observed on the introducer sheath, 25 cm from the introducer sheath''s hemostatic valve.With the hemostatic valve removed from the introducer sheath, there was no breach to the turbo-power''s outer jacket in the area of the clamp marks.Severe wrinkles were seen on the turbo-power''s outer jacket, approximately 30 cm from its distal tip.However, no breaches to the outer jacket were observed in the area of the wrinkles.Based on device evaluation and investigation, the cause of the turbo-power getting stuck within the outer sheath cannot be determined.However, the cause of the damage to the distal portion of the turbo-power''s outer jacket and inner lumen were determined to be use related.

• Brand Name: SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• 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: 14340606
• Report Number: 1721279-2022-00086
• Device Sequence Number: 5285446
• Product Code: MCW
• UDI-Device Identifier: 00813132026783
• UDI-Public: (01)00813132026783(17)231012(10)FTS21J30A
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K180694
• 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
• Report Date (Section B): 03/08/2022

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: 10/12/2023
• Device Model Number: 420-050
• Device Catalogue Number: 420-050
• Device Lot Number: FTS21J30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• 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: 04/21/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: ASAHI GLADIUS 0.018 GUIDE WIRE; COOK MEDICAL 6F ANSEL GUIDE CATHETER; COOK MEDICAL 6F ANSEL INTRODUCER SHEATH (2); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TURBO ELITE LASER CATHETER
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White