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

Model Number 518-062

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: two right ventricular (rv), models 4058m-58 and 4004m-58, and one right atrial (ra) lead, model 4269-52 due to mri, non functional lead and a redundant lead.All leads had been implanted 348 months.Spectranetics lead locking devices (lld's) were inserted into each lead to act as traction platforms to aid in the extractions.Multiple extraction tools were utilized but the lead's outer insulation was starting to break, so the physician decided to not continue with the lead extraction and cut and cap the leads.The physician attempted to unlock the lld's to remove them from the leads, but was unsuccessful at removing any of the three lld's from the leads.All three leads and lld's left within the leads were cut/capped and remained in the patient.This report captures the lld within the rv lead, model 4058m-58, and was cut, capped and remained in the patient.Please reference mdr 1721279-2020-00171 which captures the lld left in the rv lead(model 4004m-58), and mdr 17212-2020-00172 which captures the lld left in the ra lead (model 4269-52).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE 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: 10425909
• MDR Text Key: 203514535
• Report Number: 1721279-2020-00170
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)210913(10)FLP19J12A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19J12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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: MEDTRONIC 4004M-58 RV PACING LEAD; MEDTRONIC 4058M-58 RV PACING LEAD; MEDTRONIC 4269-52 RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 54 YR