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

Model Number 420-006

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information unavailable from facility.Device evaluation: the device was returned and evaluated on 10 august 2020 by a cross functional engineering team.The device was submitted with approximately 5¿ of the outer jacket removed with fibers exposed.There was a discoloration of the fibers for the first (approximately) 3¿ from the distal tip.Optical examination revealed a dried crusted debris on the fibers that was red in color.The fibers were gently scrapped with a very fine stainless steel knife to extract any particulate for analysis.Molecular analysis of numerous particles revealed spectra that was consistent with blood, talc and most often combinations of both blood and talc.There was no evidence of adhesives in any of the collected spectra.

Event Description

A peripheral laser atherectomy procedure commenced (additional case detail requested, but unavailable).A spectranetics turbo elite atherectomy catheter was being used to target a lesion.They physician reported difficulty and reported a "soft spot" and bending in the catheter.Another device was used without issue, and the procedure was completed successfully with no reported patient harm.However, after the device was returned to the manufacturer and evaluated on 10 august 2020, it was discovered that the device's outer jacket showed exposed fibers.Due to this discovery, this event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

Manufacturer Narrative

In a recent record review on 1 oct 2020, it was noted a supplemental #1 mdr was required to add and to correct information submitted in the initial mdr on 02 sept 2020.H6): patient code listed 3164 (radiation exposure, unintended) in the initial mdr.This report is being sent to correct this information; there was no exposure to radiation in this event.Patient code 2692 added (no known impact or consequence to patient).H6): device, method, results and conclusions codes submitted in the initial mdr remain accurate.Device evaluation: in the initial mdr, only the failure analysis portion of the device evaluation was submitted, and not the initial findings.The complete device evaluation is now listed below, adding in the initial evaluation of the device and conclusion of entire device evaluation: the device was returned and initially evaluated by a cross functional team on 11 june 2020.The device was lost during transit; when it was delivered it was observed that the device had little to no protection around it.Upon initial inspection, the first 10cm of the distal shaft was very stiff and multiple wrinkles were identified throughout the working length.Using a 0.014 guide wire through the distal tip, the guide wire stopped advancing about 3cm from distal tip.Using the same 0.014 guide wire through the proximal end, the guide wire stopped advancing 6-7cm from distal tip.After dissecting the outer jacket, it was confirmed that heavy biologics were in the inner lumen where resistance with the guide wire was felt.While pushing water through the port and blocking the distal tip, no obvious leaks were identified.However, heavy biologics exited out through the distal tip.The 0.014 guide wire was then reinserted and was able to make it through the entire length of the inner lumen without issue.The device was then evaluated again on 10 august to perform molecular analysis.The device was submitted with approximately 5¿ of the outer jacket removed with fibers exposed.There was a discoloration of the fibers for the first (approximately) 3¿ from the distal tip.Optical examination revealed a dried crusted debris on the fibers that was red in color.The fibers were gently scraped with a very fine stainless steel knife to extract any particulate for analysis.Molecular analysis of numerous particles revealed spectra that was consistent with blood, talc and most often combinations of both blood and talc.There was no evidence of adhesives in any of the collected spectra.For blood and talc to come in contact with fibers, a breach in the inner jacket had to occur.This breach to the inner jacket exposed the fibers to biological material.No broken fibers were identified.Because there were no broken fibers identified in the device evaluation, there was no exposure to unintended radiation.

• 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
• MDR Report Key: 10482458
• MDR Text Key: 208148475
• Report Number: 1721279-2020-00187
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)211101(10)FBA19K10A
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA19K10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other