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

Model Number 518-067

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight, pre-op labs/testing and medical history unknown.

Event Description

Lead management procedure to extract one ra lead.The lead was prepped with a lld-ez.A 16f slsii was advanced to near svc, then to significant adhesion/calcification, a cook dilator sheath was used to advance to the svc.The slsii was advanced to the tip of the lead, then the lead was extracted using countertraction.At that time, the patient's blood pressure was stable.The physician implanted the new lead using the slsii device and guidewire, then the slsii device was removed.Approximately two minutes after the old lead was extracted, the patient's blood pressure dropped and a cardiac effusion was confirmed on tee (trans-esophageal echo); location of injury unknown.Intervention via pericardiocentesis was performed and patient became stable.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6517526
• MDR Text Key: 73561625
• Report Number: 1721279-2017-00072
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP15J17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS SLSII LASER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR