MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number 545-511

Device Problems Stretched (1601); Device Dislodged or Dislocated (2923); Torn Material (3024)

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

Event Date 12/10/2015

Event Type  Injury  

Event Description

While pulling the tightrail device back out the subclavian vein- the device was longer and the outer jacket was torn.The subclavian entry point was very calcified.The patient was treated with another tightrail without complication.

Manufacturer Narrative

Device evaluation: the outer jacket was torn on the distal portion of the catheter.The inner coils appeared to have been pulled out of the distal tip but still attached to the device.The complaint narrative indicates there was significant calcification likely leading the device to become stuck onto the lead and requiring/exhibiting excessive force on the device.This is a known inherent risk of the procedure due to patient anatomical conditions.

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: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: TIGHTRAIL
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5352491
• MDR Text Key: 35682920
• Report Number: 1721279-2015-00203
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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