MAUDE Adverse Event Report: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number 545-511

Device Problems Retraction Problem (1536); Failure to Advance (2524)

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

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a lead extraction procedure to extract a ventricular electrode via jugular approach, the tightrail rotating dilator sheath would not advance beyond the tricuspid valve.The physician attempted to retract the device and was not able to pull the device back over the lead.Device and lead were both extracted by forced traction on the lead locking device.Pt.Tolerated procedure without any adverse events.

Manufacturer Narrative

Device evaluation; the blades had been locked into place within the lumen.On inspection around the blades biological material was seen between the blades and the band.Based on the complaint narrative the lead was most likely stuck inside of the tighrail due to the calcification.The lhr review did not indicate any issues with blade rotation during the manufacturing of this device.The drive assemblies are 100% checked in ri for patency and there were no recorded issues with this material lot.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: TIGHTRAIL
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5526821
• MDR Text Key: 41681909
• Report Number: 1721279-2016-00036
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K142546
• 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,Followup,Followup,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/29/2017
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK15H29A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2015
• 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): Other