SPECTRANATICS LEAD LOCKING DEVICE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for SPECTRANATICS LEAD LOCKING DEVICE UNKNOWN manufactured by The Spectranetics Corporation.

Event Text Entries

[184074890] Patient's date of birth unavailable. Device model#, lot#, catalog#, expiration date and udi unavailable. Device manufacture date unavailable because device lot# is unavailable.
Patient Sequence No: 1, Text Type: N, H10

[184074891] A lead extraction procedure commenced to remove one right ventricle (rv) lead and one right atrium (ra) lead, due to cied system and pocket infection. Spectranetics lead locking devices (lld's) were used in each of the leads to act as a traction platform to aid in extraction. The procedure started by trying to extract the rv lead first. Using a spectranetics 11f tightrail the physician cut through fibrous and calcified tissue around the lead in the left subclavian vein. While in the innominate vein with the 11f tightrail, the physician noticed the rv lead came back into the ra while traction to the rv lead was applied. It was at this time when the patient? S hemodynamics deteriorated rapidly. A tee confirmed pericardial effusion. Cpr was started and the surgical team was called urgently. The surgical team opened the chest via a sternotomy. The surgical team located the tear at the superior vena cava (svc) to right atrial (ra) junction. Patient was put on bypass and the tear was repaired. At this point both the rv and ra leads were extracted. The sternotomy was closed after a temporary epicardial ventricular lead was placed as a back-up. There was no alleged malfunction of any spectranetics devices during the procedure. The physician stated that the tear was due to traction forces being provided by the lld in the rv icd lead and not from the tightrail device, as he did not have the tightrail near the location of the tear. It was reported that the rv lead had loosened and had retracted back into the ra, and this is when the physician thinks the tear to the svc occurred. The patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00051
• MDR Report Key: 9832483
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-13
• Date of Report: 2020-02-18
• Date of Event: 2020-02-18
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-18
• Date Added to Maude: 2020-03-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. SARAH BREVIG
• Manufacturer Street: 9965 FEDERAL DRIVE
• Manufacturer City: COLORADO SPRINGS CO 80921
• Manufacturer Country: US
• Manufacturer Postal: 80921
• Manufacturer Phone: 719447-246
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SPECTRANATICS LEAD LOCKING DEVICE
• Generic Name: LLD
• Product Code: DRB
• Date Received: 2020-03-13
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE SPECTRANETICS CORPORATION
• Manufacturer Address: 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-13
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2020-03-13