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

Model Number 518-019

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth, age unk.Patient's weight unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath to successfully extract the rv lead.The 14f glidelight device was then used to attempt extraction of the ra lead.The glidelight device stalled progress in the superior vena cava (svc) region, and made very slow progress until the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon, administration of blood products and medications, and sternotomy.A 1-2 cm perforation was discovered high in the right atrium, but below the svc (mdr #1721279-2021-00234).Patient was placed on bypass and the repair was successfully completed.The physician attempted to unlock the lld from the ra lead, but was unsuccessful.The ra lead tip, containing the lld, was cut and capped and remained in the patient's body.The patient survived the procedure.This report captures the lld which was cut and capped within the ra lead tip and remained in the patient.

• 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: 12957450
• MDR Text Key: 286452902
• Report Number: 1721279-2021-00235
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)230414(10)FLC21D12A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21D12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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: (B)(4) 1944 RA PACING LEAD; (B)(4) 1948 RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White