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

Model Number 518-062

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an extraction procedure to remove a non-functional rv pacing lead, a glidelight laser catheter was utilized with an outer sheath, with a lead locking device (lld) being used for traction.Reportedly, using appropriate traction/counter-traction technique, the laser sheath was advanced to within 2 cm of the rv lead tip.The laser was not utilized beyond that point.Counter traction force was applied several times until the lead tip scarring was fatigued and released.It was observed after immediate lead removal that hemodynamics were declining, at which point surgical intervention commenced.A 1 cm rv apical tear was observed and repaired, and the patient was stabilized and treated according to hospital post-operative protocols.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6454983
• MDR Text Key: 71553933
• Report Number: 1721279-2017-00061
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/14/2018
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16L10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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 PACING LEAD 4076 (IMPL 76MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 77