MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number 545-509

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 10/04/2017

Event Type  malfunction  

Event Description

It was reported that during a lead extraction procedure to remove one cardiac lead, a tightrail device became stuck on the lead.Reportedly, the lead was prepped with an lld device and progress began with the tightrail device.At the point of the distal coil, progress stalled.Upon attempts at removal of the device, the tightrail became stuck on the lead.So as not to pull on the lead, the lld was cut and the device was removed.It was then identified that a piece of calcium had been caught between the tightrail and the lead, causing the insulation to tear, which caused the binding.Additional progress could not be made on the lead so it was removed femorally with an 8f tavi sheath.

Manufacturer Narrative

The patient demographics information is being provided.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: TIGHTRAIL
• 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: 6987114
• MDR Text Key: 91457746
• Report Number: 1721279-2017-00251
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150360
• 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
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/03/2019
• Device Model Number: 545-509
• Device Catalogue Number: 545-509
• Device Lot Number: FRH17D03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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): Other
• Patient Age: 14 YR
• Patient Weight: 55