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

Model Number 518-018

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.Relevant tests/ laboratory data unavailable.Other relevant history, pre-existing medical conditions unavailable.Device evaluation: the device was sent back in conjunction with other devices used and the lead.From the minimal information, a break in the braid and core mandrel was seen in the same location on the lld.It cannot be determined how the break occurred and more information has been requested from the physician.

Event Description

Lead extraction procedure commenced.During removal, the lead with the lld device inside got torn into two parts.Both parts successfully removed with intervention; patient was discharged in stable condition.

Manufacturer Narrative

Device re-evaluation: received additional info from physician/rep regarding the event.Re-evaluation performed by a cross functional engineering team on 12/14/2017.From this subsequent information obtained, the following conclusion was determined: the lead was compromised within the lld, which caused a high stress area on the lld leading to the lld breaking in the same location as the lead break.Results and conclusions codes added after device re-evaluation.

• 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: 7085443
• MDR Text Key: 93814525
• Report Number: 1721279-2017-00279
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/09/2019
• Device Model Number: 518-018
• Device Catalogue Number: 518-018
• Device Lot Number: FLA17F06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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): Required Intervention