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

Model Number 518-019

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

In the lld''s instructions for use (ifu), the following warning is present under 10.3 procedure (7.): warning: excessive applied traction forces may impact the lld¿s ability to disengage from a lead.

Event Description

This report is capturing the lld which was present in the rv lead, cut, capped and left in the patient.A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to non function and upgrade.Spectranetics devices in use: glidelight, tightrail, lead locking devices (lld).With use of the tightrail device and an lld in the lead, attempt was made to remove the ra lead.It was reported that the leads had been implanted for 336 months in this (b)(6) year old patient.During this attempt, a right atrial tear was discovered.Rescue efforts commenced immediately, including sternotomy.The repair was successful and the patient survived the procedure (please refer to mdr 1721279-2019-00082 capturing the ra perforation).The rv lead (along with the lld in the lead) was cut, capped and left in the patient because it seemed to be too adherent to the heart and didn''t want to do any additional harm.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8637599
• MDR Text Key: 145977470
• Report Number: 1721279-2019-00083
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)201218(10)FLC18M12A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 01/01/2005,05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC18M12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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 CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST. JUDE 4269 RA PACING LEAD; ST. JUDE 4269 RV PACING LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 100