MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

Device Problem Contamination (1120)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is unavailable from the facility.

Event Description

It was reported that during a lead extraction procedure to remove 4 infected leads, a tear to the lateral vein of the coronary sinus occurred.Reportedly, the rv lead was removed with the use of a glidelight laser sheath and an lld device for traction.The lead reportedly had implanted into the area near the coronary sinus, and when the lead detached it opened a hole in the lateral vein.A sternotomy was required to successfully repair the injury.The glidelight was then used again.At this time, a tear to the corotid artery was identified.This injury was also repaired, and the patient outcome was good.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6689084
• MDR Text Key: 79143411
• Report Number: 1721279-2017-00132
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/28/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17C23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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 ICD LEAD 6947 (IMPL. 178MO); MEDTRONIC ICD LEAD 6949; MEDTRONIC PACING LEAD 5024 (IMPL. 178MO); MEDTRONIC PACING LEAD 5524 (IMPL. 178MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR