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

Model Number 423-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.

Event Description

A peripheral atherectomy procedure commenced to treat a plaque occlusion in the patient's distal left superficial femoral artery (sfa).A stent was reportedly present in patient's sfa region prior to the procedure, and the condition of the lesion within the patient's vasculature was reported to be in poor condition.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to perform the procedure.To start the procedure, the physician used an ipsilateral access.However, the lesion was found to be very tight (severely narrowed) at the proximal sfa region.Attempt was then made to access the lesion from a retrograde approach, entering from the popliteal artery in order to cross the lesion.The physician finally could cross to 1cm from the stent's distal edge, using a knuckle wire technique with 0.035" guide wire.Afterward, using a microcatheter and other interventions, the 0.035" guide wire could cross to popliteal.Then, a 0.014" guide wire was used and the lesion was able to be crossed with use of the turbo elite device two times.Afterward, a drug coated balloon was used, dilated, and completed the procedure with no reported patient harm.However, on 18 august 2020 it was reported that an acute occlusion at the left sfa was confirmed by echocardiogram.Interventions were implemented and the patient experienced a prolonged hospitalization.In an email received on 21 august from the physician, he thought that there was no relationship between the acute occlusion and the turbo elite catheter.Although the turbo elite catheter was present in the area in which an acute occlusion was discovered, this event has been determined to be related to the procedure (the physician stated that the occlusion is a phenomenon that can occur, and it is unlikely that the use of this device was the cause) and to the patient condition (as mentioned before, the patient's lesion was in poor condition).

• 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10484131
• MDR Text Key: 207921975
• Report Number: 1721279-2020-00188
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)211126(10)FBC19L19A
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC19L19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention