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 Problems Death (1802); Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 09/15/2020

Event Type  Death  

Manufacturer Narrative

Patient''s weight unavailable.

Event Description

A lead extraction procedure commenced to remove 4 leads: right atrial (ra) and capped right ventricular (rv) leads, implanted in (b)(6) 2020, and a left ventricular (lv) and active rv lead, implanted (b)(6) 2015, due to lead malfunction.The patient had extensive comorbidities.The physician was able to successfully remove the capped and active rv leads and the lv lead.While working to remove the ra lead, a spectranetics 14f glidelight laser sheath and lead locking device(lld) were in use.While the glidelight device was lasing in the ra, the ra lead popped loose with the patient''s blood pressure then dropping.An effusion was noted on tee.Rescue efforts began immediately, including rescue balloon, but the blood pressure continued to drop.The effusion was noted to be increasing; sternotomy revealed a small tear in the right atrial appendage.The repair of the injury was successful and patient survived the procedure.The philips representative who was present at the case stated that post procedure, the patient''s condition declined and on (b)(6) 2020, the manufacturer was informed that the patient had died on (b)(6) 2020.This report is being submitted due to the lld being the traction platform within the ra lead 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10554555
• MDR Text Key: 207574796
• Report Number: 1721279-2020-00199
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)220314(10)FLP20C10A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

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: 03/14/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20C10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• 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: BIOGRONIK SETROS L60 RV PACING LEAD; BIOTRONIK COROXOTW-L85BP LV LEAD; BIOTRONIK PROTEGO SV65-18 RV ICD LEAD; BIOTRONIK SETROX S45 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR