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

Model Number	518-039
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's weight unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial lead (model 7122q) due to being a redundant, non functional lead.A right ventricular (rv) and a functional right atrial (ra) lead were also present within the patient but were not targeted for extraction.A spectranetics lead locking device was inserted into the lead to provide traction.It was reported that progress stalled within the vasculature during the procedure, so the physician chose to stop the extraction attempt.The physician attempted to unlock the lld from the lead but was unsuccessful.The ra lead, with the lld present within the lead, was cut, capped, and remained within the patient.
Additional Manufacturer Narrative
H6: 'manufacturer received an email from fda on 15 mar 2021 providing a list of mdr''s submitted by the manufacturer that included an invalid exemption number.The purpose of this supplemental report is to clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.This exemption number has now been removed.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11416430
• Report Number: 1721279-2021-00030
• Device Sequence Number: 14298390
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)210816(10)FLJ19H15A
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K043401
• Exemption Number: 5645646
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ19H15A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1581 RV ICD LEAD; ST. JUDE MEDICAL 2088 RA PACING LEAD; ST. JUDE MEDICAL 7122Q RA PACING LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR