MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem High impedance (1291)

Patient Problems Injury (2348); Pericardial Effusion (3271)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The injury that occurred during the case is captured in mdr # 1721279-2015-00139.

Event Description

This was a right-sided lead extraction procedure to remove one rv icd lead ((b)(4), implanted (b)(6)) due to high impedance.The lead was prepped with an lld #2 and a 16f glidelight laser sheath was used to extract.The laser sheath progressed down to the area of the svc/ra junction when a pleural effusion was noted on tee (no decline in blood pressure was noted).The ct surgeon immediately performed a sternotomy and an injury in the svc/ra junction was found and repaired.The physician elected to cut and cap the lead with the lld inside the lumen in lieu of continuing with the extraction.The patient survived the intervention.This report is reflecting the lld that required situational abandonment.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 5061831
• MDR Text Key: 25893991
• Report Number: 1721279-2015-00140
• 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: 09/04/2015

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: Physician
• Device Expiration Date: 01/19/2017
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC15A19A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2015
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 93