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

Model Number UNAVAILABLE

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Device lot, expiration date and complete udi number unavailable from facility device manufacture date unavailable.

Event Description

Patient showed no decline of status immediately following a lead extraction procedure; however, a week later a ''shunt'' was discovered between the right and left atrium when patient underwent echocardiogram for an unrelated issue.According to the report, it was thought to have occurred at the time of extraction of the lv lead from the cs.Patient survived the event.

Manufacturer Narrative

Additional information provided by physician to warrant correction of the mdr.Manufacturer received word from physician, who provided additional case detail.From this detail, the glidelight device listed in the initial mdr, was reported by the physician to not have been in the area of the coronary sinus where the lv (left ventricular) lead was present.The physician confirmed that an lld was present within the lead in the coronary sinus at the time the lead dislodged.This follow up corrects the device (originally the glidelight) to the lld as being present in the coronary sinus within the lead.The shunt was discovered a week after the procedure was completed.No model, lot, expiration date or udi available for the lld.The lld device was not returned for evaluation.Device manufacture date of the lld unavailable.

Event Description

Additional information received from physician regarding event: procedure commenced to remove two rv leads and one lv lead.Dr.Used glidelight device in the subclavian, svc, and ra.One rv lead successfully removed with laser; second rv lead successfully removed without any device needed.Dr.Was not able to enter the coronary sinus due to significant binding of fibrotic tissue.During removal of the rv leads, the lv lead dislodged.Md confirmed an lld was present in each of the leads, and that traction was being applied to the lv lead when it dislodged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6852549
• MDR Text Key: 85431960
• Report Number: 1721279-2017-00201
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNAVAILABLE
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• 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: SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 75