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 Vascular Dissection (3160)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth: unk. Relevant tests/laboratory data: unk. The device was discarded, thus no investigation could be completed.

Event Description

A peripheral atherectomy procedure commenced, included as part of a (b)(6) postmarket study. The procedure was an in-stent restenosis (isr) to treat a lesion in the patient's mid superficial femoral artery (sfa). The physician chose a spectranetics turbo elite laser atherectomy catheter and a drug coated balloon catheter to treat the patient. After the procedure, a grade b arterial dissection was observed after use of the turbo elite, and observed also after use of the balloon. There was no need for intervention. The procedure was completed successfully and the patient was discharged three days later with no further complications. This report captures the turbo elite device in use when the arterial dissection occurred, with no intervention required. There was no alleged malfunction of the turbo elite device in use during the procedure.

• 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: 13022388
• MDR Text Key: 285669329
• Report Number: 1721279-2021-00251
• 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

• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2022
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC20D15A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/16/2021 Patient Sequence Number: 1

Treatment

DRUG COATED BALLOON MANUFACTURER AND MODEL UNK; GUIDE CATHETER MANUFACTURER AND SIZE UNK; GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM