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

Model Number 518-039

Device Problem Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Injury (2348); Pericardial Effusion (3271)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Age, weight of patient unavailable; lot number of device unavailable; mdr filed due to lv lead end being cut and left in situ.

Event Description

Three lead removal procedure due to infection.Ra lead successfully removed using a 14f glidelight.Rv lead removal: used a 14f, 16f and 12f glidelight.At that point a small effusion was noted on tee (trans-esophageal echo).The effusion appeared to lessen and case continued with use of 13f tightrail; rv lead removed successfully.Removal of lv lead attempted with heavy traction without success.At this point, effusion worsened and rescue efforts commenced.Tear discovered at proximal wall of svc after sternotomy; tear repaired successfully.Physician went through ra to retrieve lv lead; lead was ultimately freed and removed via right atrium before cutting the end of the lead and leaving it in situ.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; n/a; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; n/a; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6453040
• MDR Text Key: 71488370
• Report Number: 1721279-2017-00060
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-039
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• 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 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention