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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Death (1802)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is not available.(b)(4).

Event Description

It was reported that during a lead extraction procedure remove two active pacing leads (ra and rv) along with 2 inactive (capped) pacing leads (ra and rv) the capped rv lead broke with a lead locking device (lld) inside of it, and was abandoned.Reportedly, the lead had been prepped with the lld and a glidelight laser sheath had been used to reach near the tip of the lead.When traction force was applied,the lead broke.A cook medical bulldog device was placed around the lead in an attempt to remove it, but was unsuccessful.Due to injuries that the patient sustained in a different part of this procedure, the patient did not survive the 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

B1): corrected to adverse event and problem.B2): outcomes now reflected as "other" since lld was cut and capped, 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 3165 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: 6549438
• MDR Text Key: 74579635
• Report Number: 1721279-2017-00077
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 08/03/2021
• Supplement Dates FDA Received: 08/09/2017; 08/09/2021
• 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); 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)
• Patient Outcome(s): Death; Other