MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING MECHANICAL DILATOR SHEATH; 13F TIGHTRAIL

Model Number 545-513

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2014

Event Type  Injury  

Event Description

This was a lead extraction procedure to remove three leads due to cied system infection and venous occlusion.A previous attempt to extract one of the leads, the sjm ra pacing (model unknown), was unsuccessful in 2010, so the lead was abandoned and a new lead (1688 ra pacing) was implanted at that time.This procedure was being done to extract all three leads (including the previously abandoned lead).The ra and rv leads were prepped with liberators and the previously abandoned atrial lead was locked with a bulldog/onetie combination.The physician used an 11f tightrail with outer sheath to extract the 1688 atrial lead successfully.Moving to the 1226 ventricular lead with the tightrail, progression was made down to the tricuspid valve when the physician switched to a 16f glidelight for about 2 minutes of lasing, then to a telescoping sheath, without further progress.At this point, the physician decided to try to extract the previously abandoned atrial lead with a tightrail.Because the 11f tightrail did not have the necessary id to accommodate this lead, a 13f tightrail was used.Progression was made with the tightrail, without outer sheath, to the distal end of the atrial lead, where the lead was inadvertently damaged by the tightrail.It was at this time that it was noted that the tightrail had also damaged the rv lead (1226) which was not the targeted lead at that time (although it was planned for extraction during the case).The physician had to snare both the rv and remaining ra lead via a femoral approach, leaving only the tip of the atrial lead behind.The physician deemed the procedure a success, commenting that the lead in question typically falls apart during an extraction.The patient experienced no adverse effects from the procedure and was discharged per operative plan.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING MECHANICAL DILATOR SHEATH
• Type of Device: 13F TIGHTRAIL
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 3884975
• MDR Text Key: 18033012
• Report Number: 1721279-2014-00101
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/16/2014
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRD14D16A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2014
• 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
• Treatment: COOK LIBERATOR LOCKING STYLET X 2; ST JUDE MEDICAL(UNK MODEL) RA PACING (IMPL 252 MO); FEMORAL SNARE (MODEL UNKNOWN); SPECTRANETICS 11F TIGHTRAIL; ST JUDE MEDICAL 1226 RA PACING (IMPL 252 MON); COOK BYRD DILATOR TELESCOPING SHEATH; COOK BULLDOG LEAD EXTENDER; ST JUDE MEDICAL 1688TC RV PACING (IMPL 51 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS 16F GLIDELIGHT; COOK ONE TIE COMPRESSION COIL
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 64