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

Model Number 518-062

Device Problem Material Separation (1562)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

A2): patient''s date of birth unk a4): patient''s weight unk b7): other relevant history unk h3/h6): the device was returned to the manufacturer and the evaluation is currently ongoing.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.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 atrial (ra) and a right ventricular (rv) lead due to lead fracture.Spectranetics lld ez lead locking devices (lld ezs) was inserted into each lead to provide traction.Multiple spectranetics devices (glidelight laser sheath, tightrail sub-c rotating dilator sheath, tightrail (long) rotating dilator sheath, visisheath dilator sheath) and a cook medical evolution dilator sheath were used during the procedure.The ra lead was successfully removed during the case without issues.While working on the rv lead, traction was being applied by the lld, and the lld separated into two pieces at the mandrel, outside the patient''s body.Therefore, a cook medical bulldog lead extender and a cook medical one-tie compression coil were used for traction; however, these devices broke as well.Then, a second bulldog, one-tie and fiber wire (mfr unk) were used, which provided adequate traction to extract the rv lead.The procedure was completed with no reported patient harm.This report captures the lld within the rv lead that separated during use, potential for harm with recurrence.

Manufacturer Narrative

G3): the device evaluation and investigation were completed 21mar2024.H3): a portion of the lld was returned.Visual inspection of the lld portion was found entangled with a lead fragment, suture, and cook medical one-tie compression coils.A cook medical bulldog lead extender was entangled with the lead fragment and the lld capture tube.During functional testing, the capture tube fell off the lld when it was freed from the bulldog, and discovered that nothing proximal to the capture tube was returned.The only lld portions returned were a small section of the lld braid and mandrel within the capture tube.Further testing confirmed three unknown wires were present within the lead fragment, with no other lld portions present.H6): based on the incomplete device returned, the cause of the damage could not be established.Type of investigation code corrected to 4116 (from 10).Investigation findings code 3243 replaced (from 3233).Investigation conclusions code 4315 replaced (from 11).All other codes remain applicable as listed in the initial mdr.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 EZ 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: 18871403
• MDR Text Key: 337862665
• Report Number: 3007284006-2024-00052
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)251128(10)FLP23L27A
• 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,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP23L27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• 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: COOK MEDICAL BULLDOG LEAD EXTENDERS.; COOK MEDICAL EVOLUTION DILATOR SHEATH.; COOK MEDICAL ONE-TIE COMPRESSION COILS.; FIBER WIRE MANUFACTURER UNK.; MEDTRONIC 5076 RA PACING LEAD.; MEDTRONIC 6949 RV ICD LEAD.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LLD EZ IN RA LEAD.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS VISISHEATH DILATOR SHEATH.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander