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

Model Number 518-022

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

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

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to infection.The rv lead was successfully removed.A spectranetics lead locking device (lld) was inserted into the ra lead to provide traction.The physician attempted extraction of the ra lead using a cook medical 9f evolution mechanical dilator sheath and a spectranetics glidelight laser sheath, but could not remove it because of strong adhesion.The physician then used a cook medical needle's eye snare and caught the vicinity of the lead tip, and using the evolution device, the lead was removed.After ra lead removal, the patient's blood pressure dropped.Transesophageal echocardiography (tee) showed an accumulation of pericardial fluid (effusion).Although drainage was done, the patient's condition did not improve.The physician performed a sternotomy and surgery was performed (specific perforation location and intervention unk).The patient survived the procedure.This report captures the lld providing traction to the ra lead when cardiac tamponade occurred resulting from a perforation, 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: 13022483
• MDR Text Key: 284522023
• Report Number: 1721279-2021-00249
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: (01)00813132023027(17)230416(10)FLD21D14A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• Device Lot Number: FLD21D14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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
• Treatment: COOK EVOLUTION MECHANICAL DILATOR SHEATH; COOK MEDICAL NEEDLE'S EYE SNARE; RA LEAD MANUFACTURER AND MODEL UNK; RV LEAD MANUFACTURER AND MODEL UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian