MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	560-013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.(b)(4).
Event or Problem 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.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 (please reference mdrs !721279-2021-00039 and 1721279-2021-00040 which capture those lld ezs present within the rv and ra leads, respectively, and were cut/capped and remained within the patient''s body).This report is being submitted to capture the subclavian injury that was initially detected with use of the 13f tightrail sub-c device.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 15 yrs old.
Additional Manufacturer Narrative
H6): added codes: 4755, 4643, 4624, 4619, and 4621.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11507179
• Report Number: 1721279-2021-00038
• Device Sequence Number: 5350138
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)221217(10)FRQ20M17A
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K161333
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: FRQ20M17A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F PEEL-AWAY SHEATH MANUFACTURER UNKNOWN; SPECTRANETICS 11F TIGHTRAIL MINI DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1642 RA PACING LEAD; ST. JUDE MEDICAL 1646 RV PACING LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 102