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

Model Number	518-022
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth and age unavailable.Patient's weight unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) lead, a left ventricular (lv) lead and a right ventricular (rv) lead with a hybrid approach of the cardiac resynchronization therapy defibrillator (crt-d) due to pocket decubitus.The physician was able to extract the lv lead using a spectranetics 11f tightrail rotating dilator sheath.The ra lead was removed with use of a spectranetics 16f glidelight laser sheath, after attempts were made using 11f and 13f tightrail devices.The physician encountered difficulty with extraction of the rv lead using the abovementioned devices, along with a spectranetics lead locking device (lld) that was inserted into the rv lead and was providing traction to aid in extraction.After several attempts to remove the rv lead, the physician decided to abandon it within the patient.It was reported that it was impossible to remove the lld from inside the lumen of the rv lead, so the physician cut both the rv lead and the lld contained within the lead, and capped them.The physician then successfully reimplanted the crt-d system from the patient's left side.The patient survived the procedure and there was no reported injury.

• 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: 11329848
• Report Number: 1721279-2021-00021
• Device Sequence Number: 934822
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: (01)00813132023027(17)220624(10)FLD20F22A
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 06/24/2022
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• Device Lot Number: FLD20F22A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other