MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 16F GLIDELIGHT

Model Number 500-303

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Pericardial Effusion (3271)

Event Date 01/11/2016

Event Type  Injury  

Event Description

Lead management case to extract one non-functional biotronik kentrox lead.During extraction with a 16f glidelight it was noted that the atrial and ventricular leads were adhered to each other so the physician experienced significant stalled progression on the rv lead.It was determined that in order to remove the rv lead safely that the ra lead would also need to be removed.A 14f glidelight was then put into use on the ra lead.With slow but steady progress the physician successfully made it to the tip of the atrial lead switching back to a 16f glidelight part of the way through.It was noted that the lead had significant scar tissue adhered to it.Once again the physician returned back to the rv lead experiencing significant resistance along the svc coil.After passing the coil the bp began to drop and a small effusion was seen.The ct surgeon performed a sternotomy revealing a tear in the svc.The tear was repaired and the extraction continued without additional complication.The patient survived the intervention.

Manufacturer Narrative

(b)(4).

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 16F GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 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: 5378459
• MDR Text Key: 36346414
• Report Number: 1721279-2016-00002
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• 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,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/21/2017
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC15K21B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 106