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

Device Problem Material Separation (1562)

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

Event Date 12/08/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead.The traction platform used for the ra lead is unk, but a spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath and alternating between the ra and rv leads, the ra lead was ultimately extracted with no issues.Then, attempting to extract the rv lead with the same 16f glidelight, progress stalled at the top of the superior vena cava (svc).Switching to a spectranetics 11f tightrail rotating dilator sheath, advancement was reached 3-4 cm from the rv lead tip; however, the tightrail became stuck on the lead.Repeated traction attempts led to ectopic heart beats and intermittent drops in the patient''s blood pressure (bp), concomitant with each traction pull.At that time, the lld in the rv lead snapped near the lld''s proximal end, out of the patient''s body.To attempt removal and to expose the lld, the tightrail''s outer jacket was incised (mdr #3007284006-2023-00093).An artery forcep was used to clamp the lld, thereby allowing a traction platform.Then, the lld, tightrail, and rv lead were extracted with no surgical intervention required.Upon removal of the rv lead, the patient''s bp dropped significantly, and recovered slowly.The patient survived the procedure.The physician suspected that the drops in bp were a vagal response, and not as a result of an injury.This report captures the lld providing traction within the rv lead which broke, requiring intervention.

Manufacturer Narrative

A2): patient''s date of birth, age unk.A3): patient''s gender unk.A4): patient''s weight unk.A5a./5b.): patient''s ethnicity/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.D4): device model number, lot number, catalog number, expiration date, and udi unk.G4): device 510k number unk because model number unk.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): although the device was discarded and the reported problem could not be confirmed, device damage is a known risk of complication with use of the lld.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.

• Brand Name: LLD LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): 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: 18373003
• MDR Text Key: 331179800
• Report Number: 3007284006-2023-00098
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• 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/MODEL/TYPE UNK; RV ICD LEAD MANUFACTURER/MODEL UNK; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention