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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because lot number unavailable.(b)(4).

Event Description

A lead extraction procedure commenced to remove 3 leads, a right ventricular (rv), right atrial (ra) and a left ventricular (lv) due to leads being non- functional.It was reported that a spectranetics lead locking device was inserted into one of the leads, but the lead location is unknown.In addition, it is unknown if the second lead had an lld inserted in it (the llds would have provided traction to aid in the leads'' extractions).The physician tried numerous tools: a spectranetics 16f glidelight laser sheath, byrd telescoping sheaths, a spectranetics 13f tightrail sub-c rotating dilator sheath, a stainless steel sheath and femoral snares.There was significant binding at the clavicle and the physician believed the leads had grown into the bone.The lv lead was successfully removed; however, it was reported that the rv and ra leads snapped at the clavicle area during removal attempt.The physician then attempted to remove the ra and rv leads femorally without success; therefore they remained in the patient''s body.There was no reported patient harm.It was reported that when the lead snapped which had an lld present within it (again, location of lead unknown), the lld was removed in its entirety from the lead.It is unknown whether an lld was present within the second lead, but it was reported that no lld in either lead remained within the patient''s body.This report is being submitted to capture the lld (in the event that it was inserted into the ra lead), which may have caused or contributed to the lead snapping at the clavicle area.Please reference mdr #1721279-2021-00088 which captures the lld (in the event that it was inserted into the rv lead), which may have caused or contributed to the lead snapping at the clavicle area and with recurrence, may contribute to an injury.There is no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): added codes: 4755 and 2199.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11828675
• MDR Text Key: 265160757
• Report Number: 1721279-2021-00087
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BYRD TELESCOPING SHEATHS; FEMORAL SNARES MANUFACTURER UNKNOWN.; MEDTRONIC 4196 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6949 RV PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; STAINLESS STEEL SHEATH MANUFACTURER UNKNOWN.
• Patient Outcome(s): Other