MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH

Model Number 500-303

Device Problems Failure To Adhere Or Bond (1031); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

Placeholder.

Event Description

Lead management procedure to extract 3 leads due to cied system/pocket infection.The physician opened the pocket and performed debridement on the lv and icd leads.The 2 passive pacing leads were adhered all the way down the lead but seemed to be free at the svc and the leads were noted to be adhered to each other.A 14f laser sheath was advanced to the svc junction.The sheath was then upsized to a 16f which slowly freed the rv lead.The ra lead eventually also came free to the svc.Both lead tips had stretched and begun to separate by this point and required additional lasing at the point of the svc/ra junction.Once removed the ra lead was noted to have a large amount of tissue adhered to it.A slow pericardial effusion was then noted and the patient's blood pressure dropped.A sternotomy was performed revealing two small tears in the svc/ra junction.The patient survived the intervention.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; CO
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5430572
• MDR Text Key: 38045552
• Report Number: 1721279-2016-00019
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/09/2017
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC15K09B
• 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: 10/09/2015
• 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
• Treatment: UNKNOWN MAN. CARDIAC LEADS (IMPL. UNK MO)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR