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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.(b)(4).

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to non function, and a redundant lead.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction to aid in the leads'' extractions.The physician chose to use a spectranetics 14f glidelight laser sheath to begin the procedure.After progress stalled in the superior vena cava (svc) region, the physician chose to upsize to a 16f glidelight device, then used a spectranetics tightrail rotating dilator sheath.It was noted that the leads were heavily fibrosed.During use of the tightrail device, a small pericardial effusion appeared (please reference mdr 1721279-2021-00067, which captures the pericardial effusion that occurred while the tightrail device was in use).There was no surgical intervention required; the small effusion did not impact the patient's blood pressure.The physician attempted to unlock the llds from both the ra and rv leads, but was unsuccessful.Both leads, each containing an lld, were cut, capped and remained within the patient's body.The patient survived, and was successfully extubated the same day.This report is being submitted to capture the lld which was present within the rv lead and was cut and capped and remained in the patient's body.Please reference mdr 1721279-2021-00068 which captures the lld present within the ra lead which was cut and capped and remained in the patient's body.

Manufacturer Narrative

H3): a portion of the lld remained in the patient, and the remaining portion was discarded, thus no investigation could be completed.H6): added codes: 4727 and 4621.

• 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: 11701988
• MDR Text Key: 255394271
• Report Number: 1721279-2021-00069
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)230125(10)FLP21A22
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21A22A
• 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: BOSTON SCIENTIFIC 0185 RV ICD LEAD; BOSTON SCIENTIFIC 4135 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 47 YR