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

Model Number UNAVAILABLE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pericardial Effusion (3271)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Device model number, lot number, expiration date, and udi are unavailable.(b)(6).Device 510k number is dependent on the model number, thus is 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 ra leads and 1 rv lead, a pericardial effusion occurred.Reportedly, the two atrial leads were removed successfully with the use of lld devices.In attempts to remove the rv lead, an sls laser sheath was used to advance down the length of the lead and free it from the vessel.At this time, traction force was applied via an lld device that was placed inside the lead and the lead detached from the myocardium.The patient's blood pressure then dropped and the surgeon was called for intervention.A pericardiocentesis was performed and the pressure stabilized.No sternotomy was necessary and the patient recovered well.

• 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: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6804048
• MDR Text Key: 83030995
• Report Number: 1721279-2017-00172
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: UNAVAILABLE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• 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
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS SLS LASER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 60