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

Model Number 518-062

Device Problem Break (1069)

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

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is not available from the facility.The device was returned to the manufacturer for evaluation.Upon inspection, it was found that the core mandrel of the device had been kinked and was broken.This damage was noted approximately 9.75 inches from the wave features on the device.

Event Description

It was reported that during a lead extraction procedure to remove 6 leads (ra, rv, lv) the lld device came apart.Reportedly, this occurred when traction force was applied to the device.When the device broke, the tip of the lld was left inside the lead.A competitor device was then used to successfully remove the lead along with the broken piece of the lld.The patient was not affected, and was discharged as planned.

• 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: 6725782
• MDR Text Key: 80465447
• Report Number: 1721279-2017-00140
• 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,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/27/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17B23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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
• Treatment: MEDTRONIC LEAD 4193-88 (IMPL. 121MO); MEDTRONIC LEAD 4194-78 (IMPL. 69); MEDTRONIC LEAD 4592-45 (IMPL. 176MO); MEDTRONIC LEAD 6937-52 (IMPL. 121MO); MEDTRONIC LEAD 6943-65 (IMPL. 176MO); MEDTRONIC LEAD 6944-58 (IMPL. 69MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS SLS LASER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR