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

Model Number 518-062

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation: physical evaluation of the device noted that the core mandrel was twisted as a result of placing the forceps on the device mandrel.The force placed on the device appropriately caused the device to fully deploy.There was no indication of a manufacturing error.

Event Description

Lead management case to extract cardiac leads.The lead was prepped with an lld and physician used forceps on the mesh of the device.The mesh of the device became distorted, preventing the device from unlocking.A cook liberator was placed on the lead and the lead with lld inside came free from the patient.The patient experienced no adverse effects from this malfunction.

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 dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6323908
• MDR Text Key: 67210481
• Report Number: 1721279-2017-00024
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/08/2018
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16F08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided; 07/24/2017
• Supplement Dates FDA Received: 02/24/2017; 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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: COOK LIBERATOR; UNK MAN. CARDIAC LEAD
• Patient Outcome(s): Other
• Patient Age: 64 YR