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

Model Number 518-062

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.A portion of the device was discarded, and a portion remained in the patient; thus no investigation could be completed.Although lld cut/cap is a known risk of complication with the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to the patient experiencing diaphyragmatic stimulation.A right atrial (ra) lead was present in the patient as well, but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the lead, along with use of suture, to provide traction.The physician began using a spectranetics 14f glidelight laser sheath, and was able to advance until the superior vena cava (svc)/atrial junction, where progress stalled.The physician removed the glidelight from the patient in order to change devices, and the patient''s blood pressure dropped.No effusion was noted via transesophageal echocardiography (tee), but fluoroscopy detected a darkening shadow when scanning the right chest wall (mdr #1721279-2023-00012).Rescue efforts began immediately, including rescue balloon, and administration of blood products.Once the blood was given to the patient, the blood pressure stabilized.The physician and surgeon decided to perform a venogram to determine the site of injury; however, no injury was observed.The rescue balloon and contrast were used twice with no further observation of injury.The physician/surgeon thought the rescue balloon tamponaded off the injury, perhaps located in the svc, since the balloon was inflated in that region.No surgical intervention was required; a leadless pacemaker was implanted, and the physician chose to abandon the rv lead.He did not attempt to unlock the lld from the rv lead prior to cutting and capping both, which remained in the patient (mdr #1721279-2023-00013).The rv lead removal was to be scheduled at a later time.The patient survived the procedure.This event captures the lld present within the rv lead which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 16238038
• MDR Text Key: 308071085
• Report Number: 1721279-2023-00013
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)241104(10)FLP22L03A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22L03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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: MEDTRONIC 5086 RA PACING LEAD; MEDTRONIC 5086 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White