MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

Model Number 500-303

Device Problems Use of Device Problem (1670); Physical Resistance (2578)

Patient Problems Death (1802); Exsanguination (1841); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 08/22/2017

Event Type  Death  

Manufacturer Narrative

Device lot number, expiration date unavailable.Device manufacture date unavailable.

Event Description

Lead extraction procedure commenced with use of 16f glidelight laser sheath.After second lead was successfully moved, resistance was encountered with forward movement of the laser and sheath.Patient became hemodynamically unstable and severe bleeding in the pocket was noted.Rescue efforts began immediately, including sternotomy.The hemorrhage was discovered to be coming from the innominate vein.Unfortunately tear could not be repaired and patient did not survive.

• Brand Name: SPECTRANETICS 16F GLIDELIGHT LASER SHEATH
• Type of Device: GLIDELIGHT
• 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: 7076701
• MDR Text Key: 93522905
• Report Number: 1721279-2017-00280
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• 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; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS SLS II LASER SHEATH
• Patient Outcome(s): Death
• Patient Age: 78
• Patient Weight: 78