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

Model Number 518-062

Device Problem Use of Device Problem (1670)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable.Patient codes: although the patient died in the procedure, the death was unrelated.To the lld being used in the procedure.Therefore, patient code 1802 was not used.Conclusions code 61 was used because the physician did not attempt to unlock the lld prior to cutting and capping the rv lead/lld.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.It was reported that the patient's subclavian vein was occluded.The pocket was opened, and the physician removed the generator of the device.The physician then prepped the rv lead with a spectranetics lead locking device (lld) to use for traction.The physician attempted to gain access into the venous vasculature using standard technique.However, during this time, bleeding was noted at the entry site (patient remained stable during this time).It was confirmed from the physician that the bleeding was related to the patient's condition, and that spectranetics devices in use did not cause or contribute to any injury.The bleeding was controlled, and a vascular consult was obtained, in which an arteriogram and venogram were performed.No injury was detected.The physician chose to abandon the procedure.He cut and capped the rv lead and lld within the lead (physician did not attempt to unlock the lld prior to cutting/capping, so there was no confirmation there was any malfunction of the lld).The lld remained within the lead within the patient.The physician then closed the pocket.Approximately an hour after the pocket was closed, the patient's blood pressure dropped and a code was implemented.The patient died; the physician confirmed that her death was related to her condition and was not related to any procedural event (actual cause of death unknown).This report is being submitted for the lld that was cut and capped and left within the patient.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9445582
• MDR Text Key: 175196048
• Report Number: 1721279-2019-00213
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960042 S067
• 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: 01/01/2005,11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• 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: 11/15/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR