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

Model Number 518-067

Device Problem Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); Iatrogenic Source (2498)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

Patient's weight was unavailable.Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.Therefore, no device evaluation can be performed.

Event Description

A philips representative reported that a cardiac lead management procedure commenced to remove a non-functional/fractured right ventricular (ev) implantable cardioverter defibrillator (icd) lead.A spectranetics lead locking device (lld) was utilized as the traction platform for the extraction.The lld snapped at the rv lead fracture area, which was at the proximal end of the coil.The patient's blood pressure dropped at that time.Rescue efforts, including cpr and sternotomy, revealed that the superior vena cava (svc) was torn during the extraction (please see mdr 1721279-2019-00136, as the svc tear is not attributed to the lld device).Rescue efforts commenced including sternotomy, and the lead was removed during open heart.Note: 4076 right atrial (ra) lead, rep believes, was taken out during the open heart along with the 0292 right ventricular (rv) lead, due to being potentially dislodged.Original intention was to just take out 0292 rv lead.The patient survived the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8852076
• MDR Text Key: 152985204
• Report Number: 1721279-2019-00137
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: 00813132023065
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 0292 ICD LEAD; MEDTRONIC 4076 PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR