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 Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove three leads: a right atrial (ra) (medtronic model 5076), and two right ventricular (rv) leads (one active (medtronic model 6935), one capped (medtronic model 6947)) due to non function.The active rv lead was targeted first.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.Using a spectranetics 11f tightrail mini rotating dilator sheath, this lead was extracted successfully.The capped rv lead was targeted next.An lld was inserted into this lead as well to provide traction, and the physician used a spectranetics 14f glidelight laser sheath, a spectranetics 11f tightrail mini device, and a spectranetics 13f tightrail rotating dilator sheath.This lead was also extracted successfully.The ra lead was the last lead targeted for removal.Using an lld inserted into the lead to provide traction, the physician used the 14f glidelight device and then an 11f tightrail mini device.The physician advanced to the svc with the 11f tightrail mini without issues and the physician started pulling traction on the lead.While applying traction, the ra lead popped free.After several seconds, the patient''s blood pressure started to drop and a pericardial effusion was detected.Rescue efforts began immediately, including rescue balloon and sternotomy.A 1.5cm tear was seen in the ra.The tear was successfully repaired, and the patient was doing well.This report is being submitted to capture the lld which was providing traction to the ra lead when a life threatening ra perforation occurred, requiring intervention.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 (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: 12222173
• MDR Text Key: 265176389
• Report Number: 1721279-2021-00141
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)230525(0)FLP21E24A
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21E24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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: 71 YR
• Patient Weight: 84