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

Model Number 518-062

Device Problem Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.(b)(4).

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to lead fracture and patient's symptom of dizziness.A temporary pacemaker was then deployed in the rv at 60 beats per minute (bpm) as the patient was pacemaker dependent.Spectranetics lead locking devices (lld ezs) were inserted into each of the leads to provide the traction platforms to aid in the leads'' extractions.The physician inserted x 2 a 7f peel-away sheath into the subclavian vein.The cas had asked the physician if all equipment and mechanical device would fit into the subclavian vein based on the venogram.Beginning with a spectranetics 11f tightrail mini rotating dilator sheath, the physician focused efforts to remove the ra lead and became caught in the mid subclavian region.He then switched efforts to removal of the rv lead.This was repeated two more times.Some bleeding was noted in the pocket, but patient was hemodynamically stable.When the 11f tightrail mini could not advance, a spectranetics 13f tightrail sub-c rotating dilator sheath was used.At this point, both the cas and cardiologist thought that there was lead on lead binding at this particular part of the subclavian vein and that there might be snowplowing of the leads'' jacket that was preventing the device from advancing.The 13f tightrail sub-c was used on the ra lead with no advancement.Effort was then switched to the rv lead and was used when it was noted that the patient was bleeding a copious amount of blood at the pocket site but remained hemodynamically stable.The physician held pressure on the site to relieve bleeding.At this point the physician suspects that there might be a suture that was binding the two leads together since the implant was performed as a cephalic cut-down.The vascular team was paged and arrived, and assessed the situation.They suspected that there was a tear in the subclavian vein.Vascular team had a hard time visualizing the origin of the bleed in the subclavian.Orthopedic (ortho) service was asked to assess.Ortho deemed it necessary to cut the subclavian bone to reach the bleeding site.Once the subclavian bone was cut, vascular was able to visualize a tear at the subclavian vein and successfully repaired it (please reference mdr 1721279-2021-00038 which captures this subclavian injury).The patient also received an autotransfusion at this time together with 1 pack of red blood cells (rbc).When the repair was complete, the explanting cardiologist made a plan with the surgeons to continue extraction.The cardiologist also spoke with another explanting physician and was agreeable to plan.The surgeons were on standby and present in the room.The explanting cardiologist used a spectranetics 16f glidelight laser sheath with a spectranetics large visisheath fitting both the ra and rv lead simultaneously into the glidelight device.Cardiologist then proceeded to advance the glidelight, lasing in the binding area in the subclavian x 2, along with manual manipulation using the visisheath.The patient started to bleed again and the surgeons stepped in to reinforce the repair (it was confirmed that the bleeding was coming from the site of the initial injury).At this point the explanting cardiologist determined that the leads would need to be abandoned and to proceed with an implantation of new leads.The explanting cardiologist cut both the ra and rv leads together with the lld ezs which were in place within each lead, capped them and they remained within the patient's body.The physician had attempted to disengage the llds from the leads but was unsuccessful.This report is being submitted to capture the lld that was present within the ra lead and was cut and capped, and remained in the patient (mdr 1721279-2021-00039 captures the lld present within the rv lead which was cut and capped and remained in the patient).It was reported that the future plan is to attempt to extract the leads femorally.After the procedure, it was discussed that there was no other way that the procedure could have been done differently.The physician believes that the lead had migrated out of the vein since it was implanted when the patient was (b)(6) yrs old.

Manufacturer Narrative

Added codes: 4727, 4633, and 4621.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11507198
• MDR Text Key: 253992926
• Report Number: 1721279-2021-00040
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7F PEEL-AWAY SHEATH MANUFACTURER UNKNOWN; SPECTRANETICS 11F TIGHTRAIL MINI DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; ST. JUDE MEDICAL 1642 RA PACING LEAD; ST. JUDE MEDICAL 1646 RV PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 102