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

Model Number NOT AVAILABLE FROM FACILITY

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Model and lot number unavailable from facility.Device manufacture date unavailable because device model and lot number is unavailable.

Event Description

Three leads (2 ra, 1 rv) being removed from patient.An lld was placed in each lead.First ra lead (from 2008) was removed successfully using a 14fr glidelight.Second ra lead (from 1996) removed with use of 14fr glidelight, 16 fr glidelight, and 13fr tightrail.However, during removal of this second ra lead, patient's bp dropped and was successfully treated with medication (no bleeding noted).A 16fr glidelight and 13fr tightrail was used to remove rv lead from 1996.Again patient's bp dropped and was successfully treated with medication (again, no bleeding noted via tee).After case was complete, surgeon was notified that patient's bp had dropped and there was a small amount of blood visible on tee on posterior side of heart.Successful interventions by physician completed and patient survived.

• 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: 6397636
• MDR Text Key: 69738778
• Report Number: 1721279-2017-00043
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NOT AVAILABLE FROM FACILITY
• Device Catalogue Number: NOT AVAILABLE FROM FACILITY
• Device Lot Number: NOT AVAILABLE FROM FACILITY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• 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 13FR TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14FR GLIDELIGHT LASER SHEATH; SPECTRANETICS 16FR GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 54