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

Model Number 518-062

Device Problem Device Slipped (1584)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 11/17/2021

Event Type  Death  

Event Description

A lead extraction procedure commenced to remove a malfunctioning right ventricular (rv) icd lead, procedure performed on the patient's right side.The patient had significant comorbidities.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician began with a cook medical 11f evolution shortie dilator sheath but was unsuccessful at advancing through the subclavian.He then chose a spectranetics 14f glidelight laser sheath.Heavy binding was present (perceived to be calcium) throughout the case, so multiple tools were used, including a spectranetics tightrail sub-c rotating dilator sheath when the 14f glidelight device failed to progress to the innominate region.After progress was successful, the physician chose a 16f glidelight device to enter the superior vena cava (svc) region.After encountering more calcium, the physician then used a cook medical 13f evolution mechanical dilator sheath, but the lead would still not come free.The lead was snared from the groin using an ep catheter and a merit medical en snare device but was unable to pull the lead away from the rv apex, and was unable to get any further past the binding while pulling down from the groin.It was noted that there might have been some shocking cable externalization at the proximal end of the lead's distal shocking coil.This was not evident pre-procedure but perhaps could have been there from the beginning or perhaps was the by-product of mechanical and laser use, coupled with a difficult procedure.Nevertheless, an attempt was made to re-prep the lead by grabbing the high voltage cables with a cook medical bulldog lead extender, as the lld appeared to be pulling back and no longer providing traction.Shocking cables were successfully secured with the bulldog device, then the 16f glidelight device was run back over the lead.Pulling on the shocking cables did allow the glidelight device to pass the binding site at the proximal end of the lead's distal shocking coil, but did not progress to the end of the shocking coil.At this time, the lead pulled free and the patient's hemodynamics deteriorated.A cardiac tamponade was detected, and rescue efforts began immediately, including pericardiocentesis, cpr and sternotomy, which revealed an rv apex perforation.The patient was placed on pump and was stabilized.Repair at first appeared successful but the bleeding continued after they thought it was repaired and the patient's condition deteriorated again.They were not able to save the patient's life.This report captures the lld providing traction within the lead.Although the patient's hemodynamics changed after use of the cook medical bulldog device, the lld was in use prior to it slipping back in the lead, and could have caused or contributed to the rv apex perforation, requiring intervention but resulting in death.

Manufacturer Narrative

Patient's date of birth unk; patient's ethnicity/race unk; relevant tests/laboratory data unk; device lot number, expiration date unk; device evaluated by mfr: the device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

• 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 (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12957506
• MDR Text Key: 281900499
• Report Number: 1721279-2021-00236
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2021
• 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
• Treatment: COOK MEDICAL 11F EVOLUTION SHORTIE DILATOR SHEATH; COOK MEDICAL BULLDOG LEAD EXTENDER; COOK MEDICAL EVOLUTION ROTATING DILATOR SHEATH; EP CATHETER MANUFACTURER AND MODEL UNK; MERIT MEDICAL EN SNARE SNARE SYSTEM; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE MEDICAL 7120Q RV ICD LEAD
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 44 KG