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

Model Number 518-062

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

Patient Problem Cardiac Perforation (2513)

Event Date 03/18/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to occlusion and non-function.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath, encountering calcium in the device pocket and subclavian region.He then switched to a spectranetics 13f tightrail sub-c rotating dilator sheath, and was able to advance through the calcium at the clavicular ligament.He then switched back to the 14f glidelight device, but encountered stalled progression at the proximal end of the lead''s superior vena cava (svc) coil, so switched to a spectranetics 13f tightrail rotating dilator sheath.After approximately fifty clicks of the tightrail, the blades would no longer rotate.While the physician was providing traction with use of the lld, the tip of the rv lead dislodged and retracted back into the svc.A new tightrail was used, and the rv lead was pulled back, and was visible in the pocket.The physician cut away the calcium in the pocket, and was able to slide the tightrail distal of the occlusion.The rv lead was pulled through the tightrail and a 0.035 guide wire was placed through the tightrail to retain access for re-implantation.A new rv lead was placed and tested, and the numbers were good.They removed the original device and placed a new one.The patient became tachycardic and a large effusion was discovered.Rescue efforts began, including chest compressions and sternotomy.A hole the size of the tip of a pinky finger was discovered and repaired, and the patient survived the procedure.The surgeon believed the perforation could have been from the re-implantation, or could have been caused by traction forces provided by the lld when the rv lead was removed.This report captures the lld providing traction to the rv lead that could have caused or contributed to the rv perforation, requiring intervention.There was no alleged malfunction of the lld used in the procedure.

Manufacturer Narrative

Patient's date of birth: unk.Patient's weight: unk.Relevant tests/laboratory data: unk.Device lot number, expiration date: unk.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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14092583
• MDR Text Key: 289207666
• Report Number: 1721279-2022-00067
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• 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: 03/18/2022
• 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: 0.035 GUIDE WIRE MANUFACTURER UNK; MEDTRONIC: 6947 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATHS (2); SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White