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 Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv) leads (one active, one capped) due to upgrading the patient to a crt-d system, removing the entire existing system to be mri compatible.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Both rv leads were successfully extracted using a spectranetics 14f glidelight laser sheath and a spectranetics 13f tightrail rotating dilator sheath.Attempting extraction of the ra lead, the physician began with the 14f glidelight device and encountered stalled progression, so switched to the 13f tightrail device.He was able to reach the tip of the lead with the tightrail, but the lead would not come free so traction and countertraction was applied, and after several minutes using the approach, the lead released.The patient remained stable after a few minutes, so the re-implantation of the new system proceeded.After placing the introducer sheath for the rv lead, it was noted that the patient''s blood pressure dropped.Medications were given and the patient responded, so the re-implantation continued, with ra and rv leads being successfully implanted.After re-implantation it was noted on transesophageal echocardiography (tee) that an effusion was present and growing.A pericardial window was performed to drain blood from the pericardial sack.Once the effusion was relieved, a sternotomy was performed.A right atrial appendage perforation was discovered, and repaired successfully.The patient survived the procedure.The physician felt that the perforation occurred during the extraction portion of the procedure.The patient did well, and was discharged after a few days.This report captures the lld providing traction to the ra lead and the right atrial appendage perforation was discovered.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: 12957265
• MDR Text Key: 285350099
• Report Number: 1721279-2021-00231
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BOSTON SCIENTIFIC 1388TC CAPPED RV PACING LEAD; BOSTON SCIENTIFIC 1388TC RA PACING LEAD; MEDTRONIC 5092 ACTIVE RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES IN RV LEADS; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White