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 Problems Perforation of Vessels (2135); Great Vessel Perforation (2152)

Event Date 09/30/2022

Event Type  Death  

Manufacturer Narrative

Patient''s weight unk.Relevant tests/laboratory data unk.Device model number, lot number, catalog number, expiration date and udi unk.Device 510k number unk because model number unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.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 a previously fractured right ventricular (rv) lead due to non function.A right atrial (ra) lead was also present in the patient but was not initially targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Using a spectranetics 14f glidelight laser sheath, spectranetics medium visisheath dilator sheath and spectranetics 11f tightrail rotating dilator sheath, the physician successfully extracted the rv lead.However, the ra lead was tested and was not functioning properly; it was believed that the tightrail blades had damaged the lead, requiring lead removal (mdr #1721279-2022-00180).An lld was inserted into the ra lead to provide traction, and the 14f glidelight and medium visisheath were used to remove the lead.The helix of the ra lead tip could not be retracted.It was discovered that the lead tip was bent (reportedly from traction forces during the procedure), and when the lead tip finally freed and the lead was being pulled out from the body, the patient''s blood pressure initially went up, then dropped.Rescue efforts began, including rescue balloon, bypass, and sternotomy.A superior vena cava (svc)/innominate perforation occurred and was successfully repaired.Likely, as traction was applied to the ra lead to remove it from the body, the ra lead tip caused the perforation in the svc/innominate region.New leads were re-implanted post-sternotomy and the patient survived the procedure.This report captures the lld providing traction to the ra lead when an svc/innominate perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

G3): philips employee became aware of patient''s death on (b)(6) 2022.H1): type of reportable event corrected from serious injury to death.H6): heic code corrected from 4619 (temporary impairment) to 1802 (death).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

Additional information received: the patient was taken off life support and expired.Cause of death was likely procedure related and not from some other cause.

• 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: 15635468
• MDR Text Key: 302055898
• Report Number: 1721279-2022-00179
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Date Manufacturer Received: 10/26/2022
• 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: MEDTRONIC 5076 RA PACING LEAD.; MEDTRONIC 5076 RV PACING LEAD.; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD.; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH.
• Patient Outcome(s): Death; Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White