MAUDE Adverse Event Report: SPECTRANETICS CORPORATION TURBO-POWER LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 420-050

Device Problem Material Separation (1562)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

A2): patient''s date of birth, age unk a4): patient''s weight unk d4): device serial number unk h3/h6): the device was returned to the manufacturer; however, the evaluation has not yet begun.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.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

A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the proximal superficial femoral artery (sfa).Prior to use of spectranetics devices, multiple tools (cook medical 6f introducer sheath, bd rotarex excisional atherectomy system) were used to begin the procedure.Per report, the rotarex distal tip broke off inside the cook sheath, and a snare was used to remove the separated portion.Then, a spectranetics turbo-power laser atherectomy catheter was loaded over a guide wire and inserted through the same cook sheath.After treatment and during removal, the turbo-power was stuck within the sheath, necessitating removal as a unit.Upon observation, exposed fibers and separation of the catheter were noted.In addition, the cook sheath''s coils/braids were loose and unraveled, bound against the turbo-power.The procedure was completed with no reported patient harm.This event is being submitted for unintended radiation exposure, potential for harm.

• Brand Name: TURBO-POWER LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): 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: 18867892
• MDR Text Key: 337856763
• Report Number: 3007284006-2024-00055
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132026783
• UDI-Public: (01)00813132026783(17)240607(10)FTS22E17A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420-050
• Device Catalogue Number: 420-050
• Device Lot Number: FTS22E17A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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: BD ROTAREX EXCISIONAL ATHERECTOMY SYSTEM; COOK MEDICAL 6F INTRODUCER SHEATH; GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American