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

Model Number	410-152
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2-a6) patient information - not available from facility.Patient information regarding relevant tests/laboratory data or medical history - not available from facility.D4) device serial number - not available from facility.The device has not been returned to the manufacturer; therefore, conclusion is not available.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 or Problem Description
A peripheral atherectomy procedure commenced to treat a distal soft tissue lesion in the anterior tibial (at) artery.During the procedure, a spectranetics turbo-elite laser atherectomy catheter was used, but the energy could not be increased at that time, the staff checked the inside packaging label and noticed a labeling discrepancy.The inside packaging label was for a 1.4 turbo-elite, and not a 0.9 turbo elite (size user intended to use), as indicated on the box label.The procedure was completed with the 1.4 turbo-elite, with no patient injury reported.This report captures the labeling discrepancy that a larger size device was contained inside the box; potential for harm.
Additional Manufacturer Narrative
D4) device serial number populated.H3) the turbo-elite and packaging were returned.Visual inspection of the box label indicated a 0.9 size; however, the pouch inside the box indicated a 1.4 size.H6) based on the device evaluation and investigation, this has been determined to be a production process related failure that was inadvertently missed during the quality control inspection.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.
Additional Manufacturer Narrative
H3/h6) in supplemental mdr #1, it was stated that the labeling discrepancy was due to a production process related failure that was inadvertently missed during the quality control inspection.However, the investigation is still on-going and the conclusion has not yet been determined.A supplemental report will be submitted upon completion of the investigation.Investigation findings code c21 (results pending completion of investigation) replaced c0502 (incorrect labeling and/or instructions for use).Investigation conclusions code d16 (conclusion not yet available replaced) replaced d0302 (quality control deficiency).All other codes remain applicable.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.
Additional Manufacturer Narrative
H6) further investigation was completed and determined that the label discrepancy did not occur during the production process.The activity log report for the shop order was reviewed, and showed that the pouch and box labeling occurred approximately 4 hrs.Apart.Review of the electronic device history record (edhr) confirmed that station clearance was performed, prior to the pouch and box labeling operations.This procedural control ensures that the work area is cleared of previous materials before new operations begin.Additionally, review of the label counts for the pouch and box reconciled with the quantities documented in the edhr.There was no time overlap noted for label printing activities between the two shop orders.Based on the device evaluation and investigation, it was confirmed that the lot numbers on the box label and pouch label do not match; however, the cause could not be established when/how the mismatch occurred.-investigation findings code updated from c21- "results pending completion of investigation" to c19- "no device problem found".-investigation conclusion code updated from d16- "conclusion not yet available" to d15- "cause not established".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: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 21707105
• Report Number: 3007284006-2025-00052
• Device Sequence Number: 4745603
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)270207(10)0303401152
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: 0303401152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 04/09/2025; 05/22/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/09/2025; 04/10/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC 0.014 CHOICE PT GUIDE WIRE.; PHILIPS LASER SYSTEM.; TERUMO 6F INTRODUCER SHEATH.
• Patient Sex: Unknown