MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

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

Patient Problems Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Patient date of birth unavailable.

Event Description

A lead extraction procedure commenced to remove an active right ventricular (rv) icd lead due to lead failure.There were a total of six leads within the patient, all accessed from the same side: an additional two capped rv icd leads, one active right atrial (ra) lead, one capped left ventricular (lv) lead and one active lv lead.The initial plan was to remove just the active rv lead.The patient had an occlusion of the superior vena cava (svc) and innominate veins due to the long standing amount and type of hardware implanted within the patient.A spectranetics lead locking device (lld) was inserted to the mid rv coil of the active rv lead.Using a spectranetics 14fr glidelight laser sheath and a medium visisheath, removal of the rv lead was attempted.Progress stalled at the patient's clavicle.The physician then chose to use a spectranetics 11f tightrail mini device, with minor advancement.The physician then utilized a 13f tightrail sub-c device, again with some minor advancement.The physician then switched back to the 14fr glidelight, and then upsized to a 16f glidelight and large visisheath devices.The active rv lead was failing by stretching apart.An attempt was made to get a wire down through the visisheath with no luck as no advancement could be made past the occlusion in the innominate vein.The decision was then made to attempt to remove one of the capped rv icd leads to gain wire access.An lld device was inserted to the tip of the lead.A 16f glidelight and large visisheath was utilized to attempt removal of this capped rv lead.The physician then switched again to the 11f tightrail mini device.The physician was able to advance over the svc coil as far as the device would progress.The physician then switched back to the 16f glidelight with a 23cm visisheath to allow more flexibility within the patient vasculature.The physician then switched to a 13f tightrail device with a teflon sheath in continued attempt to remove the capped rv icd lead.The 13f tightrail and teflon sheath reached the proximal portion of the rv coil and outer sheath made it just over the proximal portion of the rv coil, but this advancement required considerable traction (lld device being used as the traction platform).At that time, the patient's blood pressure dropped, so the physician relaxed tension on the components to allow the blood pressure to rise.After 3-4 attempts of this technique, an effusion was confirmed.After careful review of the flouro images and the tee, the decision was made to attempt pericardiocentesis.120cc of fluid was drained.Later in the procedure, an additional 120cc of fluid was drained.After that, an additional 60cc of fluid was drained, with effusion noticeably reduced.A sheath was inserted into the patient's pericardium for continued fluid removal.An additional 200cc of fluid had then collected, and the decision was made to perform a sternotomy due to continued blood collection and suspicion of an rv injury.The patient was stable at this point, and was 100% paced.A small rv free wall tear was confirmed and was successfully repaired.Per report, the patient remained stable and was doing well.The two rv icd leads which were attempted for removal were stretched and the lead components stretched out and fell apart during the extraction attempts; these two leads were capped and left within the patient.The two lld devices in these leads were removed and were not left in the patient's body.The physician felt the patient's injury was caused by traction forces.There is no alleged malfunction of any spectranetics devices used in the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• 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: 9429061
• MDR Text Key: 174178298
• Report Number: 1721279-2019-00208
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)211009(10)FLP19K07A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 01/01/2005,11/11/2019

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 Expiration Date: 10/09/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19K07A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 104