MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-067

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient date of birth unavailable.Patient weight unavailable.

Event Description

A lead extraction procedure commenced to remove two leads: a right atrial (ra) and right ventricular (rv) lead due to infection.Spectranetics lead locking devices (lld's) were inserted in each of the leads to act as traction platforms to aid in the extraction.The physician chose to attempt removal of the ra lead first.Significant adhesions were noted in the left subclavian vein with lead on lead binding.A spectranetics 12f glidelight laser sheath and a cook medical mechanical sheath were used.The ra lead was removed except for the tip of the lead, which remained.Next, the physician attempted removal of the rv lead.While using a spectranetics 14f glidelight laser sheath and a cook medical mechanical sheath, they met stalled progression.The physician chose to upsize to a 16f glidelight device.At this time, the lld present in the rv lead broke.The remnant of the lld present in the lead was successfully removed and a new lld was inserted in the rv lead.However, this lld did not engage the lead and came off from the lead, so the physician chose to no longer use an lld device and to use a snare instead, which was used successfully to remove the rv lead.Lastly, the physician attempted removal of the ra lead tip still remaining in the patient's body, using the snare.Removal of the ra lead tip was successful, but tissue was noted on the tip of the lead and the patient's blood pressure dropped.Cardiac tamponade was confirmed.Rescue efforts commenced, a sternotomy was performed and the repair to a right atrial perforation was successful.The patient survived the procedure.This report is being submitted to capture the lld which broke while attempting to remove the rv lead, due to the potential for serious injury with recurrence.However, this reported failure did not cause patient harm and was unrelated to the right atrial perforation that was reported during the lead extraction procedure.Although in use early in the procedure, there were no spectranetics devices in use during the time the right atrial perforation occurred.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• 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: 10153853
• MDR Text Key: 195124860
• Report Number: 1721279-2020-00122
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP20A03A
• 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: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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: BIOTRONIK PX45-JBP RA PACING LEAD; BIOTRONIK PX53/15-BP RV PACING LEAD; COOK MEDICAL MECHANICAL SHEATH; SNARE MANUFACTURER UNKNOWN; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATHS; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Other
• Patient Age: 73 YR