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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth: unk.Patient's weight: unk.Patient's ethnicity/race: unk.Relevant tests/laboratory data: unk.Ther relevant history: unk.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a complete dual chamber pacing system (right atrial (ra) and right ventricular (rv) leads), due to being implanted for vaso-vagal syncope, and never using the device.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted extraction of the ra lead first, using a spectranetics 14f glidelight laser sheath and a spectranetics medium visisheath dilator sheath, but encountered lead on lead binding, so switched efforts to removal of the rv lead.After working past a binding site on the rv lead, the ra lead freed up and was removed without complications.The physician continued down the rv lead, using the glidelight and the visisheath devices, and was able to work down to the tip of the rv lead.Using traction/countertraction measures to free the rv lead tip, the tip released.The physician then used an ice catheter to look for any effusion, and noted a large effusion forming.Rescue efforts began immediately, including sternotomy.An rv apex perforation was discovered.The repair was successful and the patient survived the procedure.This report captures the lld providing traction to the rv lead when an rv apex perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• 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: 13144497
• MDR Text Key: 285461589
• Report Number: 1721279-2021-00260
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)230823(10)FLC21H18A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21H18A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ICE CATHETER MANUFACTURER/MODEL UNK; MEDTRONIC 4076 RA PACING LEAD; MEDTRONIC 4092 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female