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

Model Number	560-009
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A spectranetics tightrail sub-c rotating dilator sheath was received in the philips decontamination laboratory on 05 apr 2022, sent from abbott.No complaint form or any other information was provided regarding this device; therefore, the event date is listed as 05 april 2022.The tightrail device was received disassembled, with the two handle halves separated and internal mechanisms loose within a biohazard bag.However, a visual inspection was not performed until 08 april 2022.On the tightrail device, a tag was present that states "stuck on icd".An implantable cardioverter defibrillator (icd) is a known type of cardiac lead.Within the device's inner lumen, an unidentified object was present.Further information will be available upon the completion of the device evaluation and investigation.This event is being reported conservatively due to the nature of the returned tightrail device.Due to the disassembled device, it is likely that intervention was required to remove the device from a lead.
Additional Manufacturer Narrative
Patient's date of birth and age unk.Patient's gender unk.Patient's weight unk.Patient's ethnicity/race unk.Attempts to obtain additional information have not been successful.Relevant tests/laboratory data unk.Other relevant history unk.Device lot number, expiration date unk.Initial reporter, facility information unk.The device has been received and the evaluation has begun, but is not completed at this time.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.Device manufacture date unk because lot number unk.
Additional Manufacturer Narrative
G3): the device evaluation and investigation was completed 18 may 2022.H3): the device was returned and evaluated by a cross functional team.The device was returned disassembled with biologics present throughout the device.A significant bend in the shaft was observed, 3.5 inches from the distal tip.Fragments of what appeared to be lead insulation wrapped in lead coils were removed from the distal tip.Looking at the barrel, the home track corner was slightly squared off and the far track corner was rounded.The drive shaft was unable to be manually actuated.X-ray revealed an additional foreign object present within the drive shaft.After soaking the device, additional lead fragments were pushed out the distal tip; however, the drive shaft still could not able to be manually actuated.Soaking and cross sectioning the device revealed the guide pin was in good working condition.The inner shaft was removed from the outer shaft with difficulty.Significant biologics were seen on the outside of the inner shaft.H6): the biologics in the device acted as a glue, causing the lead to become stuck in the device due to the inner and outer shaft being adhered to one another, and resulting in the device''s inability to actuate during device evaluation.A high degree of biologics likely caused the failure of the device.

• 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: 14246512
• Report Number: 1721279-2022-00078
• Device Sequence Number: 17227997
• Product Code: DRE
• UDI-Device Identifier: 00813132022785
• UDI-Public: 00813132022785
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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 Model Number: 560-009
• Device Catalogue Number: 560-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: RV ICD LEAD, MANUFACTURER AND SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown