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

Model Number	545-511
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned, thus no investigation could be completd.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to lead failure (lead had been implanted 343 months).A right atrial (ra) lead was also present in the patient, but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.A spectranetics 14f glidelight laser sheath was used first.The glidelight advanced to the innominate/superior vena cava (svc) junction then progress stalled.The physician switched to a spectranetics 11f tightrail rotating dilator sheath.During use, the mechanism of the tightrail was sticking each time the physician released the handle.He backed the tightrail out of the vessel, but was unable to completely back it off the lld.It was noted that calcium was present at the inside tip of the tightrail, so he attempted to first clear the calcium with a kelly surgical clamp, and then attempted to flush saline from the rear of the tightrail to push the clogged tissue out; both methods were unsuccessful in removing the tightrail from the lld.The physician chose to cut into the tightrail with surgical scissors to clear out the calcium, not cutting the lld in order to maintain the lead's prep and traction platform.He was successful in clearing out the calcium then backed off the remainder of the tightrail off the lld.A new tightrail was opened, rv lead was removed and the procedure was completed successfully with no reported patient harm.This report captures the tightrail which was entrapped on the lld, requiring intervention.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 17 may 2022.G3): the device evaluation and investigation were completed on 18 may 2022.H3): the device was returned and evaluated by a cross functional team.The device was returned with the distal tip cut; the distal tip was not returned.The inner coils were exposed on the distal end of the device.The shaft had no audible crepitation but it held a shape set, indicating biologics were present within the tightrail''s shaft.No blades were present to check concentricity or actuation of the drive shaft.The internal mechanisms were all in good working condition, with biologics present.Test actuations could not be performed, due to distal tip not being returned.H6): biologics discovered within the shaft of the device during the evaluation, as well as information reported in the initial complaint, led to the conclusion that excessive biologics caused the inability of the device to back off the traction platform.
Additional Manufacturer Narrative
A1): after submitting supplemental mdr #1 on (b)(6) 2022, it was discovered that the incorrect patient identifier was populated in a1.This supplemental mdr #2 corrects this number to (b)(6) (from (b)(6)).

• 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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14363818
• Report Number: 1721279-2022-00094
• Device Sequence Number: 11781550
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)231202(10)FRK21M01A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2022

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: 12/02/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21M01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 06/03/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/03/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KELLY SURGICAL CLAMP.; MEDTRONIC 4024 RV PACING LEAD.; MEDTRONIC 5076 RA PACING LEAD.; SECOND SPECTRANETICS TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White