MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a lead extraction procedure to remove two active pacing leads (ra and rv) along with 2 inactive (capped) pacing leads (ra and rv) the patient experienced a perforation to the svc and the ra wall.The active leads were removed successfully and without complication.The capped ra lead was prepped with a lead locking device and removal was attempted with a tightrail device.When traction force was applied to the lead, the lead was detached from the cardiac wall.Upon detachment, the patient blood pressure dropped, and a tear to the ra wall was identified.The lead and tightrail device were removed from the patient, at which point a tear in the superior vena cava (svc) was also identified.A bridge rescue device was used in attempts to rescue the patient, but was unsuccessful.The patient did not survive this intervention.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

Manufacturer Narrative

B2): outcomes now reflected as "required intervention" instead of "death" (captured in the initial mdr).G3): manufacturer became aware of the need for supplemental correction mdr on 03 aug 2021.H1): type of reportable event corrected to "serious injury".H3): the device was discarded, thus no investigation could be completed.H6): heic code 1802 not applicable for this report; code 2513 remains applicable for this event.Postmarket surveillance performed a record review and discovered that three mdr''s (1721279-2017-00069, 1721279-2017-00076, and 1721279-2017-00077) were submitted for "death" for the same patient.This duplicated the patient's death, which trended more deaths than actually occurred.This supplemental mdr is being submitted to change "death" to "injury", accurately reflecting the event and avoiding "death" duplication.Mdr #1721279-2017-00069 will remain unchanged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 6549441
• MDR Text Key: 74647953
• Report Number: 1721279-2017-00076
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/16/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17B11A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST JUDE MEDICAL PACING LEAD 1388T (IMPL 192MO); ST JUDE MEDICAL PACING LEAD 2088TC (IMPL 23MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST JUDE MEDICAL PACING LEAD 1388T (IMPL 192MO); ST JUDE MEDICAL PACING LEAD 2088TC (IMPL 23MO)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 45 YR