MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Difficult to Advance (2920)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 02/06/2014

Event Type  Injury  

Event Description

This was a cardiac lead extraction case to remove three leads due to cied pocket infection.The first lead, a 193 month old inactive and capped rv lead (guidant 4295), was prepped with an lld #2 and a 14f glidelight laser sheath was used to lase down to the level of the mid right atrium.Midway through the extraction, the patient was intubated because of movement during removal.During intubation, the ra lead (guidant 4271, 193 months old) was prepped with an lld #2.Lasing then resumed on the rv lead, however, progress stalled, so lasing was initiated on the ra lead.Progress then stalled on the ra lead so the 14f glidelight was withdrawn.The physician then upsized to a 16f glidelight laser catheter and returned to the rv lead.The laser catheter made it down to the apex of the rv at the tip of the rv lead when the patient's blood pressure declined.A steronotomy was performed where a series of small tears around the right atrial free wall were discovered and repaired.The leads were not removed manually during the sternotomy and the extraction was abandoned.The patient survived the intervention.The leads were removed one week later during a sternotomy.

Manufacturer Narrative

The ra perforation injury in this report is captured in ae report # 1721279-2014-00027.The second lld left inside the patient is captured in ae report # 1721279-2014-00036.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• 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: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 3648627
• MDR Text Key: 21660220
• Report Number: 1721279-2014-00035
• 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: 02/07/2014

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: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 02/26/2014
• 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: BOSTON SCIENTIFIC GUIDANT 4295 (IMPL193 MONTHS); BOSTON SCIENTIFIC GUIDANT 4271 (IMPL193 MONTHS); BOSTON SCIENTIFIC GUIDANT 4088 (IMPL 2 MONTHS); SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE #2; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 112