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

Model Number 518-022

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was returned to the manufacturer and the device evaluation is pending.

Event Description

A lead extraction procedure was performed to remove a total of two leads: the right atrial (ra) lead and the right ventricular (rv) lead due to a needed upgrade.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction to aid in the lead ''s extraction.While pulling the lld and advancing a spectranetics 12f glidelight laser sheath, the lld broke inside the lead.The rv lead was undamaged and was successfully removed by using a cook medical bulldog lead extender.The ra lead was successfully removed as well with no reported patient injury.This report captures the lld which broke inside the rv lead, requiring intervention.

Manufacturer Narrative

G3): the device investigation was completed on 01 sept 2021.H3): the device was evaluated by a cross functional team.The device''s core mandrel was broken 2.5 in from the wave feature.The entire distal section was missing and was not returned.The broken distal end was bent in a ¿j¿ shape, and the break was clean, with no obvious jagged edges.It has been determined that due to the clean break, likely the device was damaged in that area during use, then broke when traction was applied.This failure has been determined to be use related.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12396193
• MDR Text Key: 269722823
• Report Number: 1721279-2021-00164
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)220219(10)FLC20B17A
• Combination Product (y/n): Y
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• Device Lot Number: FLC20B17A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT A/V LPA1200M RA PACING LEAD.; ABBOTT A/V LPA1200M RV PACING LEAD.; COOK MEDICAL BULLDOG LEAD EXTENDER.; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR