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 Problems Perforation (2001); Perforation of Vessels (2135); Rupture (2208); Iatrogenic Source (2498)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.

Event Description

A philips representative became aware on 01 dec 2020 that a peripheral atherectomy procedure commenced on (b)(6) 2020 to treat a severely calcified lesion in the patient's mid superficial femoral artery (sfa).This procedure was part of a postmarket study conducted in japan.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the lesion.After use of the turbo elite catheter, a perforation was observed (exact location of perforation is unknown).The perforation was then treated with a plain old balloon angioplasty (poba), non drug coated, and the patient survived the procedure.There was no alleged malfunction of the turbo elite device during use in the procedure.

Manufacturer Narrative

B5): additional and corrected case detail was provided in journal article.D10): concomitant devices added.G2): additional/corrected information obtained from journal article.G3): manufacturer became aware of journal article 15nov2022.H6): hecc codes 2135 and 2208 corrected from historical codes 2498 and 2001.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

Updated information received from journal article (jacc: cardiocascular interventions, vol.14, no.23, 2021) on 15nov2022: the patient underwent the procedure for in-stent occlusion (iso).The guide wire supported with a microcatheter entered the proximal iso but could not advance any further due to hard plaque.The turbo elite advanced slowly, but was unable to pass the stents'' overlapped area due to resistance.Using a zemporshe ovalis angioscope and a philips vision pv.018 ivus catheter, an arterial perforation and rupture was identified in the tissue covering the stent, due to use of the turbo elite.Hemostasis and successful recanalization was achieved with implantation of an endovascular stent graft.

• 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: 11055418
• MDR Text Key: 223140672
• Report Number: 1721279-2020-00259
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)210930(10)FBC19J25A
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC19J25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2019
• 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
• Treatment: 0.014 GUIDEWIRE MANUFACTURER UNKNOWN; 7F INTRODUCER SHEATH MANUFACTURER UNKNOWN; MICROCATHETER MANUFACTURER AND SIZE UNK; PHILIPS VISIONS PV .018 IVUS CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ZEMPORSHE OVALIS ELECTRONIC ANGIOSCOPE; 0.014 GUIDEWIRE MANUFACTURER UNKNOWN; 7F INTRODUCER SHEATH MANUFACTURER UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention