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

Model Number 518-062

Device Problem Mechanical Problem (1384)

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

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight unavailable; device lot number, expiration date unavailable; device manufacture date unavailable.

Event Description

A lead extraction procedure commenced to remove right ventricular (rv), right atrial (ra) and left ventricular (lv) leads due to systemic infection.It was reported that the patient was (b)(6) years old with significant medical history and comorbidities.Spectranetics lead locking devices (lld's) were inserted into each lead to act as traction platforms to aid in extraction.The physician started out using a spectranetics 11f tight rail sub-c rotating dilator sheath and was able to progress to the curve of the innominate vein.He then switched to a spectranetics 14f glide light laser sheath, and was able to remove the rv lead successfully.He then concentrated efforts on the remaining lv and ra leads, switching back and forth due to adhesions, and lead on lead binding.The 14f glidelight device progressed into the ra but then progress stalled.The physician then up-sized to a 16f glidelight device and worked on the ra lead, which was then successfully removed and taken out of the body.At that time, however, the patient's blood pressure dropped.The glidelight device was removed from body and rescue efforts began immediately, including rescue balloon and sternotomy.The surgeon discovered a tear to the free wall of the ra.The repair to this area was successful and the patient survived the procedure (please reference mdr 1721279-2020-00225, which captures the ra injury while the glidelight device was in use).The lv lead, with the lld inside the lead, was cut and capped and remained in the patient's body; the physician attempted to unlock the lld within the lv lead but was unsuccessful.It was suspected that the lv lead was adhered in both the coronary sinus and vein, and would need to be extracted at a later time, due to the patient's condition.The patient was reportedly sent home on antibiotics.This report captures the lld which was present inside the lv lead and both were cut and capped, and remained in the patient's body.

• 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10801003
• MDR Text Key: 215271682
• Report Number: 1721279-2020-00226
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 44 YR