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

Model Number	518-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1721279-2021-00249
• Device Sequence Number: 20077824
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: (01)00813132023027(17)230416(10)FLD21D14A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian