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 Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.Vascular dissection is a known risk of complication with use of the turbo elite device.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

As part of a japan turbo pms study, a peripheral atherectomy commenced to treat an in-stent restenosis in the patient's left superficial femoral artery (sfa).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient, along with use of a drug coated balloon.After use of the turbo elite, angiography findings showed an arterial dissection, grade d, location unavailable.A plain old balloon angioplasty (poba) was used in the area of the dissection and afterwards, angiography showed the dissection had improved to grade b.The patient survived the procedure.This report captures the turbo elite used during the procedure and a dissection occurred, requiring intervention.There was no alleged malfunction of the turbo elite device in use during the procedure.

Event Description

This event is no longer reportable for the turbo elite device creating or contributing to an arterial dissection.Per additional information received, the physician stated the arterial dissection occurred after use of poba, not the turbo elite.

Manufacturer Narrative

B5): this event is no longer reportable after further information was received.G3): further information was received from the physician on 19dec2022.H6): based on physician''s reconsideration of event, this event is no longer reportable.H6 codes submitted on the initial mdr are no longer applicable; hecc code 4582 replaces 3160; conclusions code 67 replaces 22.The turbo elite device did not cause or contribute to the dissection that occurred during the procedure.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.

• 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15838464
• MDR Text Key: 304089803
• Report Number: 1721279-2022-00213
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC22A05A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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: DRUG COATED BALLOON MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian