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

Model Number 518-019

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

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

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) tined pacing lead due to malfunction.The plan began to extract this lead and replace it with a new ra lead.A right ventricular (rv) lead was also present in the patient but was not targeted for extraction.A spectranetics lead locking device (lld #2) was inserted within the ra lead to provide traction to aid in extraction.The physician then chose to begin the extraction with a spectranetics 14f glidelight laser sheath.The glidelight device was able to advance through the subclavian area and then encountered significant lead on lead binding between the ra and rv lead which was very scarred together throughout the innominate/superior vena cava (svc) junction.The physician encountered so much lead on lead binding that the lld #2 began to pull back due to the level of traction required to make progress and to keep the leads off the lateral wall of the vasculature.Once the lld #2 pulled back, the physician stopped and chose to go with a smaller device, choosing a 12f glidelight device, with the thought that because the lead on lead binding between the ra and rv leads was so scarred together, that the smaller glidelight device could accommodate for the tight space between the ra and rv lead.Some progress was made to the svc junction, and then progression stalled altogether.The lld #2 started coming back further so the physician chose to go back to the 14f glidelight device in order to use less traction on the lld which by this time had pulled back into the subclavian region portion of the ra lead.Very slow progress was made with the lead on lead binding with use of the 14f glidelight device, but the physician did not go around the svc bend, when the scar tissue between the leads released, followed by the patient's blood pressure dropping.This blood pressure drop was discussed between the electrophysiologist (ep) and the cardiothoracic (ct) surgeon, with the thought that this was a vagal response occurring in the patient.The ep kept the 14f glidelight device exactly where it stopped around the svc junction and the team watched for another 40 seconds, but the patient's blood pressure continued to drop.Rescue efforts began, including rescue balloon, medications, blood, bypass and sternotomy.Once the patient had stabilized, the team discovered a tear at the innominate/svc junction, exactly where there was significant scar tissue between the ra and rv leads (please reference 1721279-2021-00055 which captures the 14f glidelight device as being the last device in the area of injury when the patient's blood pressure dropped).The ct surgeon showed the ep how abnormally thin the patient's vessel wall was, and the patient's vessel wall had to be repaired in a patch like fashion in order to get the injury fully repaired, with the physicians working together to complete the repair.The physicians felt that this injury would have happened in the anatomy during lead extraction, regardless of tools used.The tined portion of the ra lead (less than 2cm) which was confirmed to have not been cut by the physician, remained in the patient's body.The rv lead remained in the patient as well, unaffected by the procedure.To complete the case, an epicardial lead was placed and the patient survived the procedure.The patient continued to improve and was discharged.It was reported that the patient was subsequently doing well and only needed an ra pacing lead now, with no heart block and no need for an rv lead.This report is being submitted to capture the lld which was present in the ra lead (confirmed to not have been cut by the physician) and significant traction was being applied to the lead, and although no injury occurred during traction, this could have caused or contributed to the portion of the ra lead remaining in the patient's body.With recurrence, this could cause or contribute to an injury.There is no evidence of malfunction of the lld in this 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: 11643087
• MDR Text Key: 244728139
• Report Number: 1721279-2021-00057
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)220818(10)FLC20H17A
• Combination Product (y/n): Y
• PMA/PMN Number: K990713
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC20H17A
• 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: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE MEDICAL 1944 RA PACING LEAD; ST. JUDE MEDICAL 1948 RV PACING LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE MEDICAL 1944 RA PACING LEAD; ST. JUDE MEDICAL 1948 RV PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 69