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

Model Number UNKNOWN

Device Problems Sticking (1597); Failure to Advance (2524)

Patient Problems Low Blood Pressure/ Hypotension (1914); Device Embedded In Tissue or Plaque (3165)

Event Date 12/17/2013

Event Type  Injury  

Event Description

This was a lead removal case performed in a hybrid or to extract one gdt 0185 cardiac lead.The case began with a 14f glidelight laser catheter with a visisheath (33cm medium).The physician could not advance, so upsized to a 16f glidelight laser catheter with the teflon sheath.When the proximal coil was reached, advancement stopped due to snowplowing.Additional pressure was being used to push the outer sheath, when the patient's vitals dropped.A ct surgeon was called, the patient was placed on bypass, and a sternotomy was performed to repair a tear in the innominate-svc junction.The lead remained stuck in the lower part of the svc or ra, and is retained, so it was cut and capped off.The patient survived the rescue.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 3590831
• MDR Text Key: 4137580
• Report Number: 1721279-2014-00008
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 01/24/2014
• 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: VISISHEATH 33CM MEDIUM; 14F GLIDELIGHT CATHETER; GDT 0185 CARDIAC LEAD; CVX-300 EXCIMER LASER; 16F GLIDELIGHT CATHETER
• Patient Outcome(s): Other
• Patient Age: 26 YR