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

Model Number UNKNOWN

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was unavailable from the user facility.Device model # and lot# could not be obtained from the site.Device expiration date cannot be determined without the lot#.Udi cannot be determined without the model #.510k cannot be determined without the device model#.Device manufactured date cannot be determined without the lot#.The device was discarded by the site.Therefore, no device evaluation can be performed.

Event Description

A philips representative reported that during a cardiac lead management procedure to extract 2 infected implantable cardioverter defibrillator (icd) leads, a spectranetics lead locking device (lld) ex was utilized to remove the leads.The first lead was successfully removed.While applying traction to remove the second lead, the lld ex broke.There was enough of the lld left over to continue traction with the spectranetics glidelight laser sheath.The second lead was successfully removed.While there was an injury to the patient during this case, which has been reported separately from this product problem under mdr 1721279-2019-00004, there was no harm to the patient caused or contributed to by the malfunction of the spectranetics lead locking device.Therefore, the two events are being reported separately.

• 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: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8242462
• MDR Text Key: 133143210
• Report Number: 1721279-2019-00005
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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
• Report Date: 01/01/2005,12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• 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: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 64 YR