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

Model Number 545-511

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by cross functional team began on (b)(6) 2019.During the evaluation, the team noticed the blades of the tightrail were not concentric with the distal band and dropped into the shaft.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 (b)(6) 2019, it was determined the guide pin material was worn and had missing material.During a meeting on 01oct2019, a meeting was held to evaluate the guide pin, and determined this to be a reportable event.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 cardiac lead extraction procedure commenced to extract 2 eroded pacing leads (1 right atrial and one right ventricular).A spectranetics tightrail rotating dilator sheath was utilized for the extraction.The tightrail met considerable resistance at suspected fibrosis at the junction of the superior vena cava (svc) and innominate vein.After multiple attempts at cutting through the fibrosis, the blades of the catheter appeared to have retracted into the outer sheath when inspected.Another tightrail device was used to complete the procedure.No harm to the patient.01oct2019: the device evaluation was completed and it was determined that this event was 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: 9175166
• MDR Text Key: 163327558
• Report Number: 1721279-2019-00174
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)201119(10)FRK18L16A
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 01/01/2005,07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK18L16A
• 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: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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
• Patient Age: 50 YR
• Patient Weight: 64