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

Model Number	501-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a 4 year old fractured right ventricular (rv) lead.A spectranetics lead locking device (lld ez) was inserted into the lead to provide traction.A cook medical bulldog lead extender was used in conjunction with the lld.The physician began by using a spectranetics 16f glidelight laser sheath and a spectranetics large visisheath dilator sheath.The philips representative, present at the procedure, stated the physician advanced halfway under the clavicle and encountered several adhesions.The physician was twisting and pushing the visisheath and believes that the bevel of the visisheath may not have been pointed down, causing the injury.When the physician reached the end of the innominate vein he continued to encounter resistance.When the physician reached the area of the tricuspid valve, the patient's blood pressure dropped.Rescue efforts began, including rescue balloon and sternotomy.A perforation in the innominate vein was discovered.The repair to the perforation was successful and the patient survived the procedure.This report captures the visisheath device being twisted and pushed in the area where the innominate perforation occurred.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient's date of birth unk.Patient's weight unk.Device lot number and expiration date unk.The device was discarded, thus no investigation could be performed.Device manufacture date unk because lot number unk in the spectranetics instructions for use (ifu) for this device, under 6.Adverse events-potential adverse events, it lists, in part:."laceration or tearing of vascular structures or the myocardium"., additionally in the ifu under 9.2.10 clinical technique - precaution, it instructs "when advancing a sheath around a bend, keep the point of the sheath's beveled tip oriented toward the inside of the bend".During the procedure, the philips representative noted that the physician was twisting and pushing the visisheath within the vessel and believes that the visisheath's bevel may not have been pointed down (toward the inside of the bend), causing the injury.

• 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
• MDR Report Key: 12749334
• Report Number: 1721279-2021-00213
• Device Sequence Number: 4489871
• Product Code: DRE
• UDI-Device Identifier: 00813132020378
• UDI-Public: 00813132020378
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2021

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 Model Number: 501-016
• Device Catalogue Number: 501-016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2021
• Initial Report FDA Received Date: 11/03/2021
• 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: MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 47 YR