MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Relevant tests/laboratory data unavailable.Device model number, lot number, catalog number, expiration date and udi unavailable.The device was discarded, thus no investigation could be completed.

Event Description

A philips (b)(6) representative became aware on (b)(6) 2021 of a lead extraction procedure commencing on (b)(6) 2021 to remove a right atrial (ra) and a right ventricular (rv) lead, extraction indication unknown.A spectranetics lead locking device (lld) was inserted into the leads to provide traction to aid in extraction.Beginning with a spectranetics 12f glidelight laser sheath, the rv lead was targeted first for removal.The team encountered severe adhesions under the clavicle and between the leads.The glidelight device's mechanical sheath was also used for peeling.The physician upsized to a 16f glidelight device, and the rv lead was removed successfully.While using a 14f glidelight device to attempt removal of the ra lead, the ra lead broke, just distal from where the lld was locked into place, leaving the tip of the ra lead embedded in the heart.There was no injury that was detected at that time, and the entire lld, along with the rest of the ra lead, were removed.The physician then used another company's snare (manufacturer unk) to retrieve the tip of the ra lead; however, he accidentally took myocardial tissue and cardiac tamponade occurred.A thoracotomy was performed to repair the ra perforation caused by the snare.The repair was successful, the ra tip remained in the patient, and the patient survived the procedure.This report captures the lld providing traction to the ra lead and the lead broke, requiring intervention to attempt removal of ra tip.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12318923
• MDR Text Key: 266415531
• Report Number: 1721279-2021-00149
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2021
• 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: RA LEAD MANUFACTURER AND MODEL UNK; RV LEAD MANUFACTURER AND MODEL UNK; SNARE MANUFACTURER UNK; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE FOR RV LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR