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

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Cardiac Tamponade (2226)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Lead management case to extract five leads due to cied/system infection.During the procedure the solute 4285 lead broke and required removal through the femoral approach.The procedure was completed successfully; however one week after the procedure, during a follow up visit, the physician confirmed a delayed cardiac tamponade due to a mediastinal hematoma.Pericardiocentesis was performed and the patient survived the intervention.The injury location is unknown therefore it is not possible to determine the exact cause of the injury.Due to the length of time necessary to discover the injury it is unlikely that the sls device used caused/contributed to the injury.It is more likely that the injury was caused by the release of the lead from the cardiac wall causing a small slow leaking perforation so this is being reported on the lld since it may have been used as the traction platform in the lead.It is not possible to know or verify at this time if any spectranetics device was a causative or contributory factor.

Manufacturer Narrative

This event was reported to spectranetics by a foreign distributor after attending a conference discussing a literary report.Very few details are available regarding this event.Placeholder.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 4606629
• MDR Text Key: 5765094
• Report Number: 1721279-2015-00042
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• 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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• 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: FINELINE 4470 LEAD (IMPL. 66 MO); EASYTRACK2 4542 LEAD (IMPL. 66 MO); SOLUTE 4294 RA LEAD (IMPL. 202 MO); SPECTRANETICS LASER SHEATH; SOLUTE 4285 LEAD (IMPL. 202 MO); ENDTAK G 0185 LEAD (IMPL. 66 MO)
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 51