MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-039
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth, age unk; patient's weight unk; relevant tests/laboratory data unk; other relevant history unk; device evaluated by mfr: the device was not returned to the manufacturer, thus the cause of the reported failure could not be confirmed.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 lead extraction procedure commenced to remove a right ventricular (rv) lead.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician used a spectranetics 13f tightrail rotating dilator sheath and during the procedure, the lld separated outside the patient, in the intermediate-distal section (unknown if within the working length).The proximal and distal sections of the lld were re-attached together and the rv lead was successfully extracted with no reported patient harm.This event captures the lld that separated during use, potential for harm with recurrence.
Additional Manufacturer Narrative
D9): the lld was returned to the manufacturer on 04apr2023.G3/h2): the device evaluation and investigation were completed 20apr2023.H3): the lld device was returned in two portions, separated at the waveform, 3.5 inches from the distal loop hypotube.The proximal portion had been flipped around and tied to the distal portion.The lld was stretched, with the diameter becoming smaller up to the area of the separation.The lld was deformed, with markings present on the proximal part of the mandrel, resembling clamp markings.H6): the cause of the reported failure could not be established based on the information provided by the distributor.No clamps were placed on the device, and the lld was used in accordance with ifu technique.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 LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• 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 ; 719447-2465
• MDR Report Key: 16515963
• Report Number: 1721279-2023-00037
• Device Sequence Number: 20407643
• Product Code: DRB
• UDI-Device Identifier: 20813132023052
• UDI-Public: (01)20813132023052(17)241018(10)FLJ22K10A
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K043401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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 Expiration Date: 10/18/2024
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ22K10A
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: RV LEAD MANUFACTURER/TYPE UNK; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White