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

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

Patient Problem Great Vessel Perforation (2152)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth and age, patient's weight, patient's ethnicity/race unk.Other relevant history unk.Device model number, lot number, catalog number, expiration date and udi unk.Device 510k number unk since model number unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk since lot number unk.

Event Description

A philips representative became aware on 03 aug 2021 of a lead extraction procedure which commenced on (b)(6) 2021 to remove a right ventricular (rv) lead due to malfunction.A spectranetics lead locking device was inserted into the lead to provide traction to aid in the lead's extraction.With use of a spectranetics glidelight laser sheath and a spectranetics visisheath dilator sheath, the rv lead was extracted successfully.However, the patient's blood pressure dropped immediately.Rescue efforts began, including rescue balloon and sternotomy.The surgeon visualized a medium sized tear in the superior vena cava (svc).According to the extractor, x ray showed a sharp angle on the lead in the superior aspect of the svc, opposite the innominate vein.However, during extraction, the lead seemed to straighten out.The tear was successfully repaired with a pericardial patch and the patient survived the procedure.It was reported the glidelight device was no longer in use when the patient's blood pressure dropped.This report captures the lld present in the rv lead when the svc perforation was discovered, 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: 12367770
• MDR Text Key: 268146757
• Report Number: 1721279-2021-00161
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 08/03/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/25/2021
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 2088 RV PACING LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention