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

Model Number 518-062

Device Problem Difficult to Remove (1528)

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

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

Device lot, expiration date and complete udi number unavailable from facility device manufacture date unavailable from facility.

Event Description

Lead extraction procedure to remove ra and rv leads due to malfunction.Rv lead was extracted successfully with use of an lld and 14f and 16f glidelight laser sheaths.Physician used a 16f glidelight and an lld to attempt ra lead removal.Traction/counter-traction was applied to the ra lead for several minutes, and during this time the patient's blood pressure began to drop.Pressers were given, patient stabilized and ra lead eventually dislodged and was extracted through the laser sheath.Laser sheath was then removed from the patient.During closing of the pocket site, it was noted that the patient's blood pressure was again dropping.At this point, surgeon was called; rescue efforts commenced and it was suspected that there was a very small hole in the ra that led to the bleeding and eventually closed off.Patient survived procedure.

• 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: 6852067
• MDR Text Key: 85371273
• Report Number: 1721279-2017-00192
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• 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: 08/17/2017
• 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 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 103