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

Model Number UNAVAILABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unavailable.Device model number, lot number and expiration date unavailable.Device 510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) lead due to non function.A right ventricular (rv) lead was present within the patient's body but was not targeted for extraction.It was reported that the patient had severe superior vena cava (svc) stenosis prior to the procedure.A spectranetics lead locking device (lld) was inserted within the ra lead to provide traction to aid in the lead's extraction.Using a spectranetics 14f glidelight laser sheath, the physician attempted to extract the ra lead.However, during use of the glidelight device, the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon and sternotomy.A tear at the svc/ra junction (immediately above this area and posterior) was discovered (please refer to mdr #1721279-2021-00017 which captures this injury that occurred while the glidelight device was in use).Repair of the tear was successful and the patient survived the procedure.According to further information received on 03 feb 2021 from the philips representative who was not present at the procedure, the ra lead was not removed and was abandoned within the patient.It is unknown whether the lld which was present within the ra lead was also cut/capped and remained in the patient, so this report is being conservatively submitted.It is also unknown, if the lld did remain in the ra lead, whether the physician attempted to unlock it prior to cutting/capping.The patient was reportedly left with svc syndrome and subsequently had a stent placed.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 11289845
• MDR Text Key: 233824285
• Report Number: 1721279-2021-00018
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 02/03/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2021
• 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: 59 YR