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

Model Number	518-067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Atrial Perforation (2511)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's weight unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and right ventricular (rv) lead due to infection.Spectranetics lead locking devices (lld's) were placed in each lead to act as traction platforms to aid in extraction.The physician began by using a spectranetics 11f tightrail sub-c rotating dilator sheath on both the ra and rv leads, successfully passing the fibrosis located in the subclavian vein.He then chose a spectranetics 11f tightrail rotating dilator sheath on the ra lead; the physician passed through significant fibrotic tissue in the superior vena cava (svc).At that time the ra lead freed and was successfully removed.Attention was then turned to removal of the rv lead.Using the 11f tightrail device, with advancement to the svc/atrial junction.The tip of the rv lead unhooked from the wall of the ventricle and moved up into the right atrium, but the rv lead was not free, with the physician unable to pass through the fibrosis in the right atrium with use of the 11f tightrail.The physician decided to upsize to a 13f tightrail device, and was able to pass over the tip of the rv lead, now located in the right atrium.While trying to push and pull and applying countertraction force (with use of the lld) in order to free the rv lead from the right atrium wall, the patient's blood pressure suddenly dropped.Rescue efforts began immediately, including rescue balloon and sternotomy.A hole in the wall of the right atrium was discovered, and was successfully repaired, with the patient's blood pressure then returning to normal.At that time, the rv lead was extracted by pulling it out of the patient's body.The patient survived the procedure.This report captures the lld which was present within the rv lead at the time the physician applied countertraction and the patient's blood pressure dropped and the ra injury discovered.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10463269
• Report Number: 1721279-2020-00176
• Device Sequence Number: 2171380
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)220228(10)FLK20B24A
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K142116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020
• Report Date (Section F): 01/01/2005

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: 02/28/2022
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK20B24A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005