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

Model Number	501-114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to rv malfunction, and ra needed to be removed to be mri compatible.Spectranetics lead locking devices (llds) were inserted in both leads to provide traction.A cook medical one-tie compression coil was used on the rv lead to provide additional traction.It was noted that the patient was occluded on the left side.A spectranetics 14f glidelight laser sheath and a spectranetics visisheath dilator sheath were used to attempt removal of the rv lead.Progress was made in the vasculature, but stalled in the innominate area.The physician alternated use of the glidelight and visisheath devices, ultimately getting through the binding in the innominate/superior vena cava (svc) region.Once through that area, the rv lead came free with traction and use of the visisheath.No hemodynamic changes were noted at the time, and no complications were seen via transesophageal echocardiography (tee).The physician noticed that the 14f glidelight was slightly bent at the tip of the device after the glidelight device was tossed to the side when the temporary pacing wire lost capture (so no issue with the device while inside the patient).The physician used a new 14f glidelight with the same visisheath to successfully extract the ra lead.There were no initial hemodynamic changes or complications.However after both leads were out and the glidelight and visisheath devices were removed and they were prepping for re-implantation on the right side due to the patient's occlusion, the patient's blood pressure dropped.Rescue efforts began, including cpr, pericardiocentesis, rescue balloon and sternotomy/bypass.A 1.5 cm perforation was identified in the innominate/svc area.The surgeon inadvertently popped the rescue balloon with scalpel (mdr #1721279-2022-00021), but patient was on bypass already so no further blood loss occurred.Repair was successful but physician stated that patient's tissues were severely friable (easily crumbled, fragile).Patient survived the procedure.This report captures the visisheath device in use when the innominate/svc perforation occurred.There was no alleged malfunction of the visisheath device in use during the procedure.

• Brand Name: SPECTRANETICS VISISHEATH DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13486240
• Report Number: 1721279-2022-00020
• Device Sequence Number: 5348880
• Product Code: DRE
• UDI-Device Identifier: 00813132020392
• UDI-Public: (01)00813132020392(17)230713(10)FMM21G13A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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: 07/13/2023
• Device Model Number: 501-114
• Device Catalogue Number: 501-114
• Device Lot Number: FMM21G13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC 0181-65 RV ICD LEAD; COOK MEDICAL ONE-TIE COMPRESSION COIL; SPECTRANETICS 14F GLIDELIGHT LASER SHEATHS; SPECTRANETICS BRIDGE OCCLUSION BALLOON; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1888TC-52 RA PACING LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White