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

Model Number 518-062

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is unavailable.Device lot number, and expiration date are unavailable.Device manufacture date is dependent on the device lot number, thus is unavailable.

Event Description

It was reported that during a lead extraction procedure to remove 2 leads (ra and rv), the atrial baffle was damaged.Reportedly, this patient had previously undergone a mustard procedure to correct transposition of the great arteries.The physician was reportedly using a glidelight laser sheath to advance down the rv lead, with an lld device within the lead for traction.When the rv lead was being removed, the ra lead was found to be stuck to it.When the leads were pulled back, the atrial baffle was damaged.A bridge rescue balloon was deployed, which allowed the hole to clot off.No further intervention was required.

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: 6641962
• MDR Text Key: 77604701
• Report Number: 1721279-2017-00111
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• 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
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR