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

Model Number	560-011
Medical Device Problem Codes	Device Damaged by Another Device (2915); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number and expiration date are not available from the facility.Device manufacture date is dependent on the device lot number, thus is unavailable.Device evaluation performed 31jul2019: device was returned disassembled.The outer shaft and strain relief had been cut.The device contained heavy biologic material.Therefore, the device was soaked for 24hrs during decontamination.The device was returned with many missing components: trigger, constant force spring, end cap, bushing, screws to the handle.During testing the barrel could be rotated within the sleeve with force.Sleeve tab was slightly deformed.Barrel analysis: far track corner intact and good condition, barrel was slightly proud of the sleeve in the far track.Home track corner was intact and in good condition.Barrel and sleeve were flush in the home track.Heavy biologic material present in the barrel.Through-hole was clear in the barrel could not attempt drop test due to heavy build up of biologic material inside of right and left handle halves had damage.
Event or Problem Description
A philips representative reported that during a cardiac implantable cardioverter defibrillator (icd) lead extraction procedure a spectranetics 11fr tightrail sub-c mechanical dilator sheath became stuck on a lead when used in conjunction with a cook medical one-tie device.The physician used the cook one-tie to bind all the cables of the icd lead together.When he tried to remove the spectranetics tightrail there was resistance.He was able to remove the tightrail from the body, but not the lead.He then disassembled the tightrail in an aggressive fashion as he did not have a sterile screwdriver for the screws.He was able to cut away the segment over the obstruction and found it to be the tightrail.The physician had to dismantle the spectranetics tightrail device in vivo, but attributes the malfunction to the use of the cook one-tie.There was no harm to the patient.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8888846
• Report Number: 1721279-2019-00141
• Device Sequence Number: 2876640
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: 00813132022792
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005