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

Model Number 420-006

Device Problems Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 09/28/2021

Event Type  Injury  

Event Description

A peripheral procedure commenced to treat an in-stent restenosis (isr) in the mid left common iliac vein.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient, and was aware that use of the device within the venous system is currently not an indication for use.While in use, the device's distal marker band detached inside the patient's vessel.The marker band was successfully retrieved from the patient with a wire and balloon.The procedure was completed using a second device with no reported patient harm.During initial device evaluation, a breach to the device's outer jacket was discovered.This report is to capture the turbo elite device when its marker band detached within the patient, requiring intervention, and inadvertent radiation exposure.

Manufacturer Narrative

Patient's date of birth unk.Relevant tests/laboratory data unk.Device evaluation: the device was returned and evaluated by a cross functional team on (b)(6) 2021.A kink was seen 24 in from the distal tip, and a breach to the device's outer jacket was seen in this area but no broken fibers were present.The marker band was returned detached from the distal tip of the catheter.Looking at the laser sheath, the device's distal tip had a void in the locking feature.Looking at the distal marker band, the locking feature was present the entire inner circumference.The outside and inside diameters of the band were the correct sizes.The internal undercut feature was the correct size and in the correct location.The marker band met specifications for the overall turbo elite device.The investigation is still ongoing.A supplemental mdr will be submitted to capture findings and conclusions codes when investigation is complete.

Manufacturer Narrative

G3): investigation concluded on (b)(6) 2021 by (b)(4).H3): upon further investigation, there was an epoxy void in the locking feature at the device''s distal tip.H6): the epoxy is applied during production of the device; therefore, this failure is determined to be production process related.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• 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: 12694532
• MDR Text Key: 282491615
• Report Number: 1721279-2021-00198
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)220623(10)FBA20F15A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2022
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA20F15A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 0.018 GUIDE WIRE; CORDIS 10F INTRODUCER SHEATH; PHILIPS 10F QUICK CLEAR GUIDE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; WIRE AND BALLOON MANUFACTURERS UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White