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

Model Number 545-513

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information is unavailable from the facility.The device was returned and evaluation by a cross functional engineering team began on 14aug2019.During the evaluation, the team noticed the blades of the tightrail were not concentric with the distal band and the device was full of biological material.The team attempted to soak the device to remove the biological material; however, the device was still unable to actuate after soaking.The device was sent to be cross-sectioned in order to evaluate the guide pin and cam path which allows the blades to extend and retract.During further evaluation on 24sep2019, a piece of metal material was found within the cam path.On 25sep2019, the piece of material was determined to be the broken guide pin material.Although no patient injury occurred this is now determined to be a reportable event due to the potential for the guidepin material to enter the patient bloodstream if this issue were to recur during use within a patient.The team was unable to determine how the piece of guide pin material was broken.

Event Description

A cardio defibrillator lead extraction procedure commenced.A 13fr tightrail rotating dilator sheath was utilized for lead removal.Thru angiography it was seen that the device did not advance, for this reason it was taken out of the patient to check it.It was found that the device blades did not turn in the right way and did not extend out like normal.Another tightrail was used to complete the procedure.No harm to patient.On 25sep2019 during evaluation of device, it was determined that a piece of metal material was found within the cam path.On 25 september 2019, the piece of material was evaluated to be the guide pin material.Due to potential for injury with recurrence from the material dislodging, this event became reportable.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9168863
• MDR Text Key: 177429061
• Report Number: 1721279-2019-00171
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)201206(10)FRJ18M06A
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K142546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ18M06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• 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