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

Model Number 518-062

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

Patient Problem Cardiac Perforation (2513)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove 4 leads: an active and a capped right ventricular (rv), one right atrial (ra) and one left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (12f glidelight laser sheath, 14f glidelight, 13f tightrail sub-c rotating dilator sheath, 13f tightrail rotating dilator sheath) were in use.The physician used the devices between all leads to allow advancement in the vasculature, since stalled progress was met multiple times.Ultimately, the active rv, ra and capped rv leads were successfully removed.While attempting removal of lv lead, it was discovered the lead was falling and extending apart in the superior vena cava (svc) region.It was also discovered that pre-procedure, the lead itself had looped down into the rv and back up into the coronary sinus.The physician used the 14f glidelight to attempt to go around the loop of the lead within the rv, but was unsuccessful because the device was too stiff, so a spectranetics 11f tightrail rotating dilator sheath was used.The tightrail was able to go around the loop, and stopped 2-3 inches from the opening of the coronary sinus os (opening) where the physician applied traction only, to attempt release of the lv lead.The patient's blood pressure dropped, and rescue efforts began immediately, including sternotomy.A coronary sinus perforation was discovered; the perforation was successfully repaired and the lv lead was removed.The patient survived the procedure.The surgeon stated that the lv lead was implanted in a very small branch and from what he could visualize, it would not have come out with traction or tools because it was embedded/stuck in this branch.This report captures the lld within the lv lead, applying traction when the coronary sinus 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15591255
• MDR Text Key: 301628876
• Report Number: 1721279-2022-00177
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)240829(10)FLP22H25A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22H25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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: SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1056T LV LEAD; ST. JUDE MEDICAL 1888TC RA PACING LEAD; ST. JUDE MEDICAL 7120 CAPPED RV PACING LEAD; ST. JUDE MEDICAL 7122Q ACTIVE RV PACING LEAD
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic