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

Model Number UNAVAILABLE

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is not available from the facility.Device model number, lot number, expiration date, and udi are unavailable.Device 510k is dependent on the device model number, thus is unavailable.Device manufacture date is dependent on the device lot number, thus is unavailable.

Event Description

It was reported that during a lead extraction procedure to remove 2 leads (ra and rv), an injury to the rv apex occurred.Reportedly, there was a level of lead on lead binding down to the point of the apex.Removal of the leads was first attempted with a tightrail device, and then with an sls laser sheath, both without success.At this point, counter-traction force was applied with an lld device with both lead within an outer sheath.The leads were then freed, although a portion of the rv apex was removed along with the rv lead.A sternotomy was immediately performed and the injury was successfully repaired with sutures.

• 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: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6824831
• MDR Text Key: 83834095
• Report Number: 1721279-2017-00181
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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
• Report Date: 08/03/2017

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 Model Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/28/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR