MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 545-513

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Great Vessel Perforation (2152); Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 01/13/2021

Event Type  Death  

Manufacturer Narrative

Patient's date of birth unavailable.

Event Description

A (b)(6) year old female patient presented with a pocket erosion and infection.The following cardiac leads were present in her body: a right atrial (ra) lead model 4086, a left ventricular (lv) lead model 4518, a cut and capped right ventricular (rv) lead model 0184 and another rv lead model 0181.Due to the recurrent infection and pocket erosion, where the leads and generator eroded through her skin, a lead extraction procedure commenced to remove all four leads.To begin the extraction, the physician placed a spectranetics lead locking device (lld ez) inside the 0181 rv lead, to act as the traction platform to aid in extraction.With use of a spectranetics 16f glidelight laser sheath, the lead was successfully removed.Next, the ra lead model 4086 was prepped with an lld ez and successfully removed utilizing the same 16f glidelight device.The lv lead model 4518 was targeted next, prepped with an lld ez and was removed with traction alone.Lastly, the rv lead model 0184 was targeted for extraction.The lead was prepped with an lld #2, and with use of the 16f glidelight, binding was encountered in the area of the superior vena cava (svc)/innominate region.After several attempts to get through this binding site with the 16f glidelight, the physician chose to use a spectranetics 13f tightrail rotating dilator sheath.The tightrail device easily advanced to the area where the 16f glidelight device had stalled.The physician actuated the tightrail device several times and slowly but surely was able to advance down the svc.Another binding site was encountered in the area of the svc/ra junction.Even after several attempts, the tightrail could not advance.The physician retracted the tightrail device and at that time, an effusion was noticed.Prior to this, the patient's blood pressure was stable and no effusion was noticed.Tamponade was then identified.Rescue efforts began immediately, including rescue balloon, pericardiocentesis, and creation of a sub-xiphoid window by the surgeon.A thumb sized hole was identified in the area of the svc/ra junction.A sternotomy was then performed, and the patient was placed on bypass.The repair was then completed successfully, and the last rv lead was removed.The patient was successfully taken off of bypass.However, within minutes of being taken off of bypass, the patient's condition deteriorated.According to the physician, her heart ¿simply failed¿, and she died on the procedure table.The physicians believe that the severe binding on the svc coil of the rv lead ultimately resulted in the injury at the svc/ra junction, as the 13f tightrail device advanced over this area.There was no alleged malfunction of any spectranetics device in use during the procedure.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 11276660
• MDR Text Key: 230210133
• Report Number: 1721279-2021-00015
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)210520(10)FRJ19E17A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150360
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ19E17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• 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): Death
• Patient Age: 78 YR
• Patient Weight: 68