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

Model Number 518-019

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information requested but unavailable.Device evaluation: the device was returned to spectranetics and evaluated on (b)(6) 2018.Visual examination found all parts are present except for the epoxy plug on the very end of the device.It was reported that the epoxy plug on the tip of the lld device was present.It was reported that the epoxy plug on the end of the device was bent, and when the attempt was made to straighten the lld, the epoxy plug broke off.Under microscopic examination, it was confirmed that the epoxy tip was missing.

Event Description

A spectranetics lead locking device (lld) was being prepared for use in a procedure.When the lld was still in the sheath, it was noted that the tip of the device was bent out of the sheath.When the physician attempted to straighten the tip, it reportedly broke off.The device was put aside and a new device was opened with the procedure being completed successfully with no reported patient harm.This event is being reported due to the potential of serious injury/death if this event were to recur and the device was used for a procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7950079
• MDR Text Key: 123402466
• Report Number: 1721279-2018-00134
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 01/01/2005,09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC17H15A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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
• Patient Outcome(s): Other