MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

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

Patient Problems Cardiac Tamponade (2226); Iatrogenic Source (2498)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: patient's date of birth unavailable at this time.

Event Description

A lead extraction case commenced to remove three leads: one left ventricular (lv), one right ventricular (rv), and one right atrial lead (ra).The physician began the procedure by extracting the lv lead using a spectranetics lead locking device (lld) and spectranetics glidelight laser sheath.The lld was placed through the coronary sinus to extract the lv lead.During the extraction of the lv lead an rv effusion was noted.While the lld moved through the coronary sinus, it is unable to be determined if the lld could have caused the effusion in the rv.Once the lv lead and lld had been removed, the physician stated the effusion had improved.No further intervention was required; the patient remained hemodynamically stable through the lv lead extraction.The patient sustained a superior vena cava (svc) injury also during this event, but is not related to the lld device present within the lv lead.The svc injury is captured in mdr 1721279-2019-00079, for reference.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica dominguez ; 9965 federal drive; colorado springs, CO 80921 ; 719447-258
• MDR Report Key: 8612847
• MDR Text Key: 145143581
• Report Number: 1721279-2019-00077
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)210131(10)FLP19A31A
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19A31A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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: MEDTRONIC 4193 CRT LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 ICD RV LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Weight: 100