MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 14F GLIDELIGHT

Model Number 500-302

Device Problem Insufficient Information (3190)

Patient Problem Great Vessel Perforation (2152)

Event Date 06/10/2015

Event Type  Injury  

Event Description

Left-sided lead extraction to remove two non-functional leads.Rv lead (mdt 5076, impl 60 months) was extracted using a glidelight and lld.A perforation in the svc occurred resulting in a hemothorax in the right lung.No interventions were necessary as the physician believed the patient would self-seal the injury.It is unclear if the injury occurred as the glidelight was being removed after the extraction or as the sheath was being introduced to place the new lead.The physician elected not to extract the ra lead (mdt 5076) as planned.The patient will return at a later time for another rv lead and possible lv lead upgrade.

Manufacturer Narrative

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• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 14F GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4869685
• MDR Text Key: 6047476
• Report Number: 1721279-2015-00100
• Device Sequence Number: 1
• Product Code: DRB
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/25/2015
• 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 LEAD LOCKING DEVICE (LLD); MDT 5076 RV PACING LEAD (IMPL 60 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MDT 5076 RA PACING LEAD (IMPL 60 MON)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR