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

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Great Vessel Perforation (2152); Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 01/15/2020

Event Type  Death  

Event Description

A lead extraction procedure commenced to remove two right ventricle (rv) leads, one of which was capped, a right atrium (ra) lead, and a left ventricle lead (lv) due to occlusion.When the physician was using the spectranetics 14f glidelight laser sheath on the capped rv lead to extract it, the patient's blood pressure dropped.Rescue interventions then commenced.A sternotomy was performed and a superior vena cava/right atrium (svc/ra) tear was discovered and attempted to be repaired.Rescue interventions were not successful and the patient expired.No leads were removed during the procedure.The physician believes that while lasing on the lead, the glidelight device jumped forward, causing the injury.However there was no alleged malfunction of the glidelight device, nor any other spectranetics devices used during the procedure.

Manufacturer Narrative

Phone call occurring on 12 feb 2020 between pms analyst and rep present at the procedure: rep informed pms analyst that he spoke with the physician after the case and the details of the case changed.The physician reportedly communicated that a hole in the right atrium (ra) was the injury location, likely due to traction from the spectranetics lead locking device (lld) present in the ra lead used in the procedure, rather than the injury location first reported and submitted in the initial mdr.Lld lot #: flp19g08a.The corrected information was reportedly received after the rep had submitted the complaint form to postmarket surveillance.This follow up mdr reflects a correction in the device which was in use during the procedure and likely to have caused or contributed to the injury in the right atrium.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9700113
• MDR Text Key: 178777339
• Report Number: 1721279-2020-00031
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)210912(10)FGB19J07A
• 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
• Report Date: 01/01/2005,01/15/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19G08A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 4056 RV PACING LEAD (CAPPED); BOSTON SCIENTIFIC 4543 LV LEAD; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE 1488 RA PACING LEAD; ST. JUDE 1590 ICD RV LEAD; BOSTON SCIENTIFIC 4056 RV PACING LEAD (CAPPED); BOSTON SCIENTIFIC 4543 LV LEAD; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE 1488 RA PACING LEAD; ST. JUDE 1590 ICD RV LEAD
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 68