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

Model Number 560-011

Device Problems Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unavailable from the site.Lot#, expiration date, and manufacture date of device are unavailable from the site.Device was soaked prior to evaluation.Confirmed heavy damage to outer jacket.Wrinkling and tearing were present, starting at tip and extending 2.5 inches.A suture could be seen hanging out the back side of handle.Handle was disassembled for inspection.Significant bio-material was observed on entire handle insides; all components were heavily soiled.Rear trigger tabs exhibited heavy wear, strain relief was adhered to shaft.Attempted to actuate device with handle.Unable to actuate, could not see through lumen; suture stuck on something inside.Device was soaked for a second time and it was determined that part of a cardiac lead was stuck in the device.After removal of lead fragment, the device functioned properly.Lead fragment occluding the lumen is likely what caused the actuation to stop.No damage to barrel, sleeve, or internal shaft of the tightrail was noted.No failure of internal device components.

Event Description

A philips representative reported that during a cardiac lead management surgery on (b)(6) 2018, after use in the patient, the distal end of the tightrail 560-011 device had significant crimping of material.The surgery was for the removal of a single non-functional right ventricle (rv) implanted cardiac defibrillator (icd) lead.After the procedure, the pocket was reportedly closed and the patient was discharged per operative plan.On 13 september 2018, during device evaluation, a cardiac lead was found lodged inside the device and a suture was discovered extending out the back side of the handle of the device.Thus, it was determined this event is reportable because although there was no reported patient harm, there is the potential for serious injury and/or death with recurrence, if a cardiac lead or suture cannot be removed from a tightrail device during a procedure.

• 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: 7920061
• MDR Text Key: 122163761
• Report Number: 1721279-2018-00130
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: 00813132022792
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K161333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• 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: 09/13/2018
• 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
• Patient Age: 73 YR