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

Model Number	560-011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation (2001); Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	05/02/2019
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove 3 leads: a left ventricular (lv) lead, a right atrial (ra) lead and a right ventricular lead (rv) due to infection.Spectranetics devices in use: 14f glidelight laser sheath, 11f tightrail sub-c device, and lead locking devices (lld).The lv lead was removed without incident with just traction - no spnc tools at all (no lld either).The physician then pulled on the ra lead (no lld at this time) - lead released but became stuck in the superior vena cava (svc)/innominate area.The physician then pulled on the rv lead (no lld at this time) and the lead released but became stuck in same area that the ra lead was stuck in, and the leads became crossed in this area.The physician then utilized lld''s for the ra and rv leads; they could not be advanced all the way to the tip of the leads due to the leads being crossed.A 14f glidelight used first to attempt to get through a binding site, and progression stalled at the clavicle.The physician then tried using the tightrail sub c device to get past the binding.While attempting to get through this area, the physician lost the ''rail'' (straightening of the leads so the devices could follow down the lead for extraction) on the leads due to the leads ''shredding''.He could not gain the rail, and pulled both the ra and the rv leads out, along with the lld''s.Immediately after the rv lead was out, the patient's blood pressure dropped.Rescue efforts began immediately including use of additional devices, fluids, epinephrine and sternotomy, where tears were discovered in the subclavian vein and mammary artery.The areas were repaired successfully; however the patient could not come off the balloon pump after several attempts.The physician reported that the patient's tissue was very difficult to repair.The physician felt the tightrail sub c cut the subclavian and stated there was a ''shark bite'' in the mammary artery, attributing this to the tightrail sub c as well.

• 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: 8638426
• Report Number: 1721279-2019-00084
• Device Sequence Number: 1844821
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)190912(10)FRP17J12A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 05/02/2019
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2019
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP17J12A
• Was Device Available for Evaluation?: No
• 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: 05/02/2019
• Initial Report FDA Received Date: 05/23/2019
• 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: Death; Life Threatening
• Patient Age: 83 YR
• Patient Weight: 78
• Date Report Sent to FDA: 01/01/2005