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

Model Number 518-018

Device Problem Contamination (1120)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Diminished Pulse Pressure (2606)

Event Date 01/02/2018

Event Type  Injury  

Event Description

It was reported that during a lead extraction procedure to remove one infected cardiac lead (rv), an injury occurred leading to death.Reportedly, the lead was prepped with an lld device, and a glidelight device was used to remove the lead.No signs of effusion or cardiac tamponade were present initially.Post extraction, a declining pressure was noticed, and after several minutes of attempted medical stabilization, the surgeon was called in.The extracting physician deployed a bridge rescue balloon and did a pericardiocentesis after confirmation of cardiac tamponade.The pressure increased and surgeon decided to perform a sternotomy.The balloon was deflated and a 1 cm tear was found at the apex of the rv.Bleeding remained persistent upon initial repair while identifying a second tear of < 0.5 cm on the svc.The patient went into vt and expired.

Manufacturer Narrative

B2): outcomes now reflected as "required intervention" instead of "death" (captured in the initial mdr).G3): manufacturer became aware of the need for supplemental correction mdr on (b)(6) 2021.H1): type of reportable event corrected to "serious injury".H3): the device was discarded, thus no investigation could be completed.H6): heic code 1802 not applicable for this report; hecc code 2513 remains applicable for this event.Postmarket surveillance performed a record review and discovered that two mdr''s (1721279-2018-00009 and 1721279-2018-00010) were submitted for "death" for the same patient.This duplicated the patient''s death, which trended more deaths than actually occurred.This supplemental mdr is being submitted to change "death" to "injury", accurately reflecting the event and avoiding "death" duplication.Mdr #1721279-2018-00009 will remain unchanged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7218399
• MDR Text Key: 98206790
• Report Number: 1721279-2018-00010
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: 518-018
• Device Catalogue Number: 518-018
• Device Lot Number: FLA17G26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS VISISHEATH DILATOR SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 59