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

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Cardiac Tamponade (2226)

Event Date 09/26/2016

Event Type  Death  

Manufacturer Narrative

Event Description

(b)(6) male presents for upgrade to an upgrade to his pacemaker, with total venous occlusion.The leads were prepped with spectranetics lld's and a spectranetics tightrail was used to disrupt the adhesions using the lld as a traction platform.Approximately 35 minutes after the rv lead extraction, the patient lost blood pressure.A cardiac echo was performed and a cardiac tamponade was diagnosed.The surgeon was notified and a pericardiocentesis was performed.The patient was stabilized and transferred to surgery where he expired.This report is being made against the spectranetics lld as the traction platform.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 6038198
• MDR Text Key: 57764725
• Report Number: 1721279-2016-00146
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• 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: CARDIAC LEAD, SJM 2088 (IMPL. 24 MOS.); SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Death
• Patient Age: 64 YR