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

Model Number	560-011
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices (ldds) were inserted into each lead to provide traction.The physician chose a spectranetics tightrail sub-c rotating dilator sheath to attempt removal of the rv lead.As the doctor was trying to take the tightrail device off the lead to use a different tool, the lead became stuck inside the tightrail device.The doctor had to cut the tightrail device in order to break up some of the tissue that was causing the tightrail device to be stuck.After this, he was able to back the tightrail device off the lead.He then removed the rv lead with a 13f tightrail rotating dilator sheath.All leads were removed and nothing remained in the patient's body.The procedure was successful and there was no reported patient harm.This report captures the tightrail sub-c device which became stuck on the rv lead, requiring intervention.
Additional Manufacturer Narrative
Device evaluation: the device was returned and evaluated by a cross functional team on (b)(6) 2021.The device was returned in 2 pieces, with the device's shaft cut 3/8 inch from the distal end of the device's strain relief.Heavy biologics were seen in the cut portion of the shaft and in the distal tip.The inside handle halves were in good working condition and heavy biologics were present.The barrel and sleeve were in good working condition; however, heavy biological build-up prevented the sleeve from rotating around the barrel.After soaking the barrel and the sleeve, the sleeve rotated around the barrel and functioned as intended.There is no indication of a design or production issue, and no indication of use-related failure.According to the report and the results of the device evaluation, the failure has been determined to be caused by excessive biologic buildup in the shaft, which is the reason the device became stuck on the lead.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12674605
• Report Number: 1721279-2021-00193
• Device Sequence Number: 1507135
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)230511(10)FRP21E11A
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP21E11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL 13F SUB-C DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 90