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

Model Number 518-062

Device Problems Device Operates Differently Than Expected (2913); Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Excessive Tear Production (2235); Foreign Body In Patient (2687)

Event Date 10/28/2016

Event Type  Injury  

Event Description

This (b)(6) yo female presented for extraction of a dual-coil mdt sprint fidelis (6949) lead.The lead was prepared for extraction by attempting to retract the helix, this was unsuccessful.A spectranetics lead locking device was inserted into the mdt (6949) lead.A 14fr.Glidelight was used for the procedure.The patient experienced hemodynamic changes when the laser reached the ra.A spectranetics bridge balloon was placed on the back table and threaded up the femoral wire that was placed pre-operatively.Once advanced into the svc, the bridge guidewire was inadvertently removed, which may cause instability of the balloon.The balloon was inflated and under fluoroscopy, conformed to the svc, however patient status remained unchanged.Cpr was begun as the cardiac surgeon arrived.The injury was described as a tear of the svc.During the intervention, the mdt 6949 lead was cut and remains in the patient.The patient did not survive the procedure.This report is made against the lld being left within the patient.A report will be made on the glidelight in this case; 1721279-2016-00172.

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): archived device code 2887 corrected to 2993.Archived patient code 2513 remains applicable for this event.Postmarket surveillance performed a record review and discovered that three mdr''s (1721279-2016-00171, 1721279-2016-00172 and 1721279-2016-00173) 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 #1721279-2016-00172 will remain unchanged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• MDR Report Key: 6114308
• MDR Text Key: 60411695
• Report Number: 1721279-2016-10171
• 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,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• 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: CARDIAC LEAD, MDT 4524 (IMPL. 252 MOS.); CARDIAC LEAD, MDT 6949 (IMPL. 127 MOS.); CARDIAC LEAD: LV UNKNOWN MFR. (IMPL.252 MOS); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; CARDIAC LEAD, MDT 4524 (IMPL. 252 MOS.); CARDIAC LEAD, MDT 6949 (IMPL. 127 MOS.); CARDIAC LEAD: LV UNKNOWN MFR. (IMPL.252 MOS); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Death; Other
• Patient Age: 62 YR