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

Model Number	560-013
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unk.Relevant tests/laboratory data unk.The device was not returned, thus no investigation could be completed.Because the physician did not maintain continuous control of the outer sheath, this event has been determined to be use related.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead, extraction indication unk.A right atrial (ra) lead was present in the patient but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician chose a spectranetics glidelight laser sheath and a spectranetics tightrail sub-c rotating dilator sheath (and the tightrail's outer sheath) to treat the patient.While the tightrail sub-c was in use, the outer sheath was inadvertently lost in the patient's vasculature.Using multiple tools, the ct and vascular surgeons assisted in successfully retrieving the outer sheath from the innominate/superior vena cava (svc) junction.The rv lead was successfully removed, and the patient survived the procedure.This event captures the tightrail sub-c's outer sheath which migrated into the vasculature, requiring intervention for retrieval.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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 ; 719447-2465
• MDR Report Key: 16315256
• Report Number: 1721279-2023-00017
• Device Sequence Number: 15002842
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)231129(10)FRQ21L29A
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: FRQ21L29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICE.; ST. JUDE MEDICAL 2088TC RA PACING LEAD.; ST. JUDE MEDICAL 7121 RV ICD LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White